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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03578081
Other study ID # A221602
Secondary ID NCI-2017-02410UG
Status Completed
Phase Phase 3
First received
Last updated
Start date October 15, 2018
Est. completion date May 1, 2023

Study information

Verified date May 2023
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase III trial studies how well olanzapine with or without fosaprepitant work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control nausea and vomiting in patients during chemotherapy. Olanzapine is usually given in combination with other drugs, including fosaprepitant dimeglumine. It is not yet known if olanzapine when given with other drugs, is still effective without using fosaprepitant dimeglumine for controlling nausea and vomiting.


Description:

PRIMARY OBJECTIVES: I. To compare between the two study arms the proportion of patients with no nausea for the overall (0-120 hours post-chemotherapy), acute (0-24 hours post-chemotherapy), and delayed periods (24-120 hours post-chemotherapy) for patients receiving highly emetogenic chemotherapy (HEC). SECONDARY OBJECTIVES: I. To compare between the two study arms the complete response (CR) rates (no emetic episodes and no use of rescue medication) in the acute, delayed, and overall periods. II. To compare between the two study arms, the incidences of potential toxicities that have been ascribed to olanzapine. III. To perform an economic evaluation of olanzapine and fosaprepitant dimeglumine (fosaprepitant) versus (vs.) olanzapine in patients receiving HEC (noting that all patients will also receive dexamethasone and a 5HT3 receptor antagonist). IV. To explore the efficacy of olanzapine in chemotherapy cycles two to four, for patients who elect to continue on the same antiemetic regimen received in cycle one, in chemotherapy cycles two to four (continuation phase), by documenting nausea and complete response. V. To explore the safety of olanzapine in chemotherapy cycles two to four, for patients who elect to continue on the same antiemetic regimen received in cycle one, in chemotherapy cycles two to four (continuation phase), by recording any adverse events or drug related toxicities. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive palonosetron hydrochloride intravenously (IV) over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or orally (PO) on day 1, dexamethasone PO on days 1-4, fosaprepitant dimeglumine IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, placebo IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment (with no placebo) may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study, patients are followed up periodically.


Recruitment information / eligibility

Status Completed
Enrollment 690
Est. completion date May 1, 2023
Est. primary completion date November 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of malignant disease of any stage; (stage I through stage IV) - No prior history of chemotherapy for any malignancy - Scheduled to receive intravenous HEC (highly emetogenic chemotherapy) (either cisplatin-containing regimen or doxorubicin and cyclophosphamide [AC]); cisplatin, given on a single day, at a dose of >= 70 mg/m^2, with or without other chemotherapy agent(s) OR doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) - No nausea or vomiting =< 24 hours prior to registration - Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only * A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) - No known diagnosis of dementia; patients with stable treated brain metastases are eligible to participate - No known history of central nervous system (CNS) disease (e.g. seizure disorder) - No treatment with another antipsychotic agent such as olanzapine, risperidone, quetiapine, clozapine, phenothiazine or butyrophenone =< 30 days prior to registration - No chronic phenothiazine administration as an antipsychotic agent (patients may receive prochlorperazine and other phenothiazines as rescue anti-emetic therapy but not within 24 hours prior to registration) - No use of amifostine within 7 days prior to registration - No radiotherapy within 7 days prior to registration or planned for one week after the current dose of chemotherapy - No use of quinolone antibiotic therapy within 7 days prior to registration - No chronic alcoholism (as determined by the investigator) - No known hypersensitivity to olanzapine - No known uncontrolled cardiac arrhythmia, no known uncontrolled congestive heart failure, or no acute myocardial infarction within the previous six months - No history of uncontrolled diabetes mellitus, i.e., no diabetic ketoacidosis; within 6 months prior to registration; patients are eligible if they have controlled diabetes on diet, oral agents, and/or insulin - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 - Patients must be able to read and comprehend English; local translation, including verbal translation of patient-reported outcomes (PROs) is not permitted - Serum creatinine =< 2.0 mg/dL =< 120 days prior to registration - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN) =< 120 days prior to registration

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Palonosetron Hydrochloride
Given IV
Ondansetron Hydrochloride
Given IV or PO
Dexamethasone
Given PO
Fosaprepitant Dimeglumine
Given IV
Olanzapine
Given PO
Other:
Placebo
Given IV

Locations

Country Name City State
Guam FHP Health Center-Guam Tamuning
United States Hawaii Cancer Care - Savio 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States The Queen's Medical Center - West Oahu 'Ewa Beach Hawaii
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Aultman Alliance Community Hospital Alliance Ohio
United States Saint Anthony's Health Alton Illinois
United States American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic PC - Ames Ames Iowa
United States Community Hospital of Anaconda Anaconda Montana
United States Saint Vincent Anderson Regional Hospital/Cancer Center Anderson Indiana
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Anne Arundel Medical Center Annapolis Maryland
United States PCR Oncology Arroyo Grande California
United States AdventHealth Infusion Center Asheville Asheville North Carolina
United States Hematology Oncology Associates of Central New York-Auburn Auburn New York
United States MultiCare Auburn Medical Center Auburn Washington
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States The Medical Center of Aurora Aurora Colorado
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Louisiana Hematology Oncology Associates Baton Rouge Louisiana
United States Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana
United States LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Medical Center of Baton Rouge Baton Rouge Louisiana
United States Ochsner High Grove Baton Rouge Louisiana
United States Our Lady of the Lake Medical Oncology Baton Rouge Louisiana
United States Our Lady of the Lake Physicians Group - Medical Oncology Baton Rouge Louisiana
United States Woman's Hospital Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States Northwell Health Imbert Cancer Center Bay Shore New York
United States Houston Methodist San Jacinto Hospital Baytown Texas
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States Overlake Medical Center Bellevue Washington
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Walter Reed National Military Medical Center Bethesda Maryland
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States University of Iowa Healthcare Cancer Services Quad Cities Bettendorf Iowa
United States Billings Clinic Cancer Center Billings Montana
United States Saint Vincent Frontier Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Elizabeth Boardman Hospital Boardman Ohio
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States McFarland Clinic PC-Boone Boone Iowa
United States Boulder Community Foothills Hospital Boulder Colorado
United States Boulder Community Hospital Boulder Colorado
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Bozeman Deaconess Hospital Bozeman Montana
United States Cox Cancer Center Branson Branson Missouri
United States IHA Hematology Oncology Consultants-Brighton Brighton Michigan
United States Saint Joseph Mercy Brighton Brighton Michigan
United States James J Peters VA Medical Center Bronx New York
United States New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn New York
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States University of Vermont and State Agricultural College Burlington Vermont
United States University of Vermont Medical Center Burlington Vermont
United States Fairview Ridges Hospital Burnsville Minnesota
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Loyola Center for Health at Burr Ridge Burr Ridge Illinois
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cambridge Medical Center Cambridge Minnesota
United States Aultman Health Foundation Canton Ohio
United States IHA Hematology Oncology Consultants-Canton Canton Michigan
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Caro Cancer Center Caro Michigan
United States Saint Anthony Regional Hospital Carroll Iowa
United States Carson Tahoe Regional Medical Center Carson City Nevada
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Sandra L Maxwell Cancer Center Cedar City Utah
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Rocky Mountain Cancer Centers - Centennial Centennial Colorado
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States Ralph H Johnson VA Medical Center Charleston South Carolina
United States IHA Hematology Oncology Consultants-Chelsea Chelsea Michigan
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Saint Luke's Hospital Chesterfield Missouri
United States Cheyenne Regional Medical Center-West Cheyenne Wyoming
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Prisma Health Cancer Institute - Laurens Clinton South Carolina
United States AdventHealth Infusion Center Haywood Clyde North Carolina
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Baptist Memorial Hospital and Cancer Center-Collierville Collierville Tennessee
United States University of Missouri - Ellis Fischel Columbia Missouri
United States Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus Mississippi
United States Mercy Hospital Coon Rapids Minnesota
United States Baptist Health Corbin Corbin Kentucky
United States Northshore Oncology Associates-Covington Covington Louisiana
United States Ochsner Hematology Oncology North Shore - Covington (West Region) Covington Louisiana
United States Carle on Vermilion Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio
United States Dayton Veterans Affairs Medical Center Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
United States Cancer Center of Colorado at Sloan's Lake Denver Colorado
United States Colorado Blood Cancer Institute Denver Colorado
United States Denver Health Medical Center Denver Colorado
United States National Jewish Health-Main Campus Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States The Women's Imaging Center Denver Colorado
United States Western Surgical Care Denver Colorado
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Illinois CancerCare-Dixon Dixon Illinois
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Epic Care-Dublin Dublin California
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Mayo Clinic Health System Eau Claire Hospital-Luther Campus Eau Claire Wisconsin
United States Mayo Clinic Health System-Eau Claire Clinic Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Baptist Health Hardin Elizabethtown Kentucky
United States Arnot Ogden Medical Center/Falck Cancer Center Elmira New York
United States Bay Area Breast Surgeons Inc Emeryville California
United States Epic Care Partners in Cancer Care Emeryville California
United States Walter Knox Memorial Hospital Emmett Idaho
United States Mountain Blue Cancer Care Center - Swedish Englewood Colorado
United States Swedish Medical Center Englewood Colorado
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Illinois CancerCare-Eureka Eureka Illinois
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States JCHC McCreery Cancer Center Fairfield Iowa
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Sanford South University Medical Center Fargo North Dakota
United States Parkland Health Center - Farmington Farmington Missouri
United States Cape Fear Valley Health System Fayetteville North Carolina
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Augusta Health Center for Cancer and Blood Disorders Fishersville Virginia
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Aurora Health Center-Fond du Lac Fond Du Lac Wisconsin
United States McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa
United States Trinity Regional Medical Center Fort Dodge Iowa
United States Holy Cross Hospital Fort Lauderdale Florida
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Unity Hospital Fridley Minnesota
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Central Care Cancer Center - Garden City Garden City Kansas
United States CaroMont Regional Medical Center Gastonia North Carolina
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Tidelands Georgetown Memorial Hospital Georgetown South Carolina
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States Glens Falls Hospital Glens Falls New York
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States National Jewish Health-Western Hematology Oncology Golden Colorado
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Altru Cancer Center Grand Forks North Dakota
United States Grand Valley Oncology Grand Junction Colorado
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Prisma Health Greenville Memorial Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Self Regional Healthcare Greenwood South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Baptist Cancer Center-Grenada Grenada Mississippi
United States Legacy Mount Hood Medical Center Gresham Oregon
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Forrest General Hospital / Cancer Center Hattiesburg Mississippi
United States Hattiesburg Clinic - Hematology/Oncology Clinic Hattiesburg Mississippi
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States 21st Century Oncology-Henderson Henderson Nevada
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States Las Vegas Urology - Green Valley Henderson Nevada
United States Las Vegas Urology - Pebble Henderson Nevada
United States OptumCare Cancer Care at Seven Hills Henderson Nevada
United States Urology Specialists of Nevada - Green Valley Henderson Nevada
United States AdventHealth Hendersonville Hendersonville North Carolina
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States Loyola Medicine Homer Glen Homer Glen Illinois
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Hawaii Diagnostic Radiology Services LLC Honolulu Hawaii
United States Island Urology Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Kuakini Medical Center Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States Tripler Army Medical Center Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Oncology Center of The South Incorporated Houma Louisiana
United States Terrebonne General Medical Center Houma Louisiana
United States Houston Methodist Hospital Houston Texas
United States Houston Methodist West Hospital Houston Texas
United States Methodist Willowbrook Hospital Houston Texas
United States Edwards Comprehensive Cancer Center Huntington West Virginia
United States Saint Mary's Medical Center Huntington West Virginia
United States Centerpoint Medical Center LLC Independence Missouri
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Mayo Clinic in Florida Jacksonville Florida
United States McFarland Clinic PC-Jefferson Jefferson Iowa
United States Capital Region Southwest Campus Jefferson City Missouri
United States Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Straub Medical Center - Kahului Clinic Kahului Hawaii
United States Castle Medical Center Kailua Hawaii
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States Research Medical Center Kansas City Missouri
United States Ochsner Medical Center Kenner Kenner Louisiana
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States First Dayton Cancer Care Kettering Ohio
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Kingman Regional Medical Center Kingman Arizona
United States Mayo Clinic Health System-Franciscan Healthcare La Crosse Wisconsin
United States Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin
United States Good Samaritan Medical Center Lafayette Colorado
United States Northwell Health/Center for Advanced Medicine Lake Success New York
United States Sparrow Hospital Lansing Michigan
United States 21st Century Oncology Las Vegas Nevada
United States 21st Century Oncology-Fort Apache Las Vegas Nevada
United States 21st Century Oncology-Vegas Tenaya Las Vegas Nevada
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Ann M Wierman MD LTD Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States Desert West Surgery Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada
United States Hope Cancer Care of Nevada Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States Las Vegas Prostate Cancer Center Las Vegas Nevada
United States Las Vegas Urology - Cathedral Rock Las Vegas Nevada
United States Las Vegas Urology - Pecos Las Vegas Nevada
United States Las Vegas Urology - Smoke Ranch Las Vegas Nevada
United States Las Vegas Urology - Sunset Las Vegas Nevada
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at MountainView Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States University Cancer Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Urology Specialists of Nevada - Central Las Vegas Nevada
United States Urology Specialists of Nevada - Northwest Las Vegas Nevada
United States Urology Specialists of Nevada - Southwest Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Kansas Institute of Medicine Cancer and Blood Center Lenexa Kansas
United States Minimally Invasive Surgery Hospital Lenexa Kansas
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Lewistown Hospital Lewistown Pennsylvania
United States Baptist Health Lexington Lexington Kentucky
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Cancer Partners of Nebraska - Pine Lake Lincoln Nebraska
United States Nebraska Hematology and Oncology Lincoln Nebraska
United States Southeast Nebraska Cancer Center - 68th Street Place Lincoln Nebraska
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Hope Cancer Clinic Livonia Michigan
United States Saint Mary Mercy Hospital Livonia Michigan
United States Logan Regional Hospital Logan Utah
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Sky Ridge Medical Center Lone Tree Colorado
United States Tibor Rubin VA Medical Center Long Beach California
United States Baptist Health Louisville Louisville Kentucky
United States McKee Medical Center Loveland Colorado
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States Baptist Health Madisonville/Merle Mahr Cancer Center Madisonville Kentucky
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Mayo Clinic Health Systems-Mankato Mankato Minnesota
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States Saint Vincent Hospital Cancer Center at Marinette Marinette Wisconsin
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States McFarland Clinic PC-Marshalltown Marshalltown Iowa
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Contra Costa Regional Medical Center Martinez California
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Loyola University Medical Center Maywood Illinois
United States Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park Illinois
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Middlesex Hospital Middletown Connecticut
United States Aurora Cancer Care-Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Minneapolis VA Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Memorial Regional Cancer Center Day Road Mishawaka Indiana
United States Community Medical Hospital Missoula Montana
United States Ochsner LSU Health Monroe Medical Center Monroe Louisiana
United States Monticello Cancer Center Monticello Minnesota
United States Saint Claire Regional Medical Center Morehead Kentucky
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States Intermountain Medical Center Murray Utah
United States Mercy Health Mercy Campus Muskegon Michigan
United States Saint Alphonsus Medical Center-Nampa Nampa Idaho
United States Houston Methodist Saint John Hospital Nassau Bay Texas
United States Baptist Health Floyd New Albany Indiana
United States Baptist Memorial Hospital and Cancer Center-Union County New Albany Mississippi
United States CarolinaEast Medical Center New Bern North Carolina
United States CarolinaEast Oncology and Hematology Associates New Bern North Carolina
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States NYP/Weill Cornell Medical Center New York New York
United States Cancer Center of Kansas - Newton Newton Kansas
United States Lakeland Hospital Niles Niles Michigan
United States Faith Regional Health Services Carson Cancer Center Norfolk Nebraska
United States Great Plains Health Callahan Cancer Center North Platte Nebraska
United States Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Tumor Institute Oakland California
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
United States McKay-Dee Hospital Center Ogden Utah
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Cancer Specialists - Omaha Omaha Nebraska
United States Oncology Hematology West PC Omaha Nebraska
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottumwa Regional Health Center Ottumwa Iowa
United States Menorah Medical Center Overland Park Kansas
United States Owensboro Health Mitchell Memorial Cancer Center Owensboro Kentucky
United States Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi
United States Baptist Health Paducah Paducah Kentucky
United States Hope Cancer Care of Nevada-Pahrump Pahrump Nevada
United States Desert Regional Medical Center Palm Springs California
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Mayo Clinic Hospital in Arizona Phoenix Arizona
United States Phoenixville Hospital Phoenixville Pennsylvania
United States Berkshire Medical Center - Cancer Center Pittsfield Massachusetts
United States 21st Century Oncology-Pontiac Pontiac Michigan
United States Hope Cancer Center Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Jefferson Healthcare Port Townsend Washington
United States Legacy Good Samaritan Hospital and Medical Center Portland Oregon
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Pottstown Hospital Pottstown Pennsylvania
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Fairview Northland Medical Center Princeton Minnesota
United States Illinois CancerCare-Princeton Princeton Illinois
United States Utah Valley Regional Medical Center Provo Utah
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Northwest Hospital Center Randallstown Maryland
United States Rapid City Regional Hospital Rapid City South Dakota
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Radiation Oncology Associates Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Valley Medical Center Renton Washington
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Reid Health Richmond Indiana
United States Riverton Hospital Riverton Utah
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic in Rochester Rochester Minnesota
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States OSF Saint Anthony Medical Center Rockford Illinois
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota
United States Dixie Medical Center Regional Cancer Center Saint George Utah
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Lakeland Medical Center Saint Joseph Saint Joseph Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States LDS Hospital Salt Lake City Utah
United States Utah Cancer Specialists-Salt Lake City Salt Lake City Utah
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania
United States Regional West Medical Center Cancer Center Scottsbluff Nebraska
United States Mayo Clinic in Arizona Scottsdale Arizona
United States Community Medical Center Scranton Pennsylvania
United States Geisinger Medical Oncology-Selinsgrove Selinsgrove Pennsylvania
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States HSHS Saint Nicholas Hospital Sheboygan Wisconsin
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Welch Cancer Center Sheridan Wyoming
United States LSU Health Sciences Center at Shreveport Shreveport Louisiana
United States Ochsner LSU Health Saint Mary's Medical Center Shreveport Louisiana
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Memorial Hospital of South Bend South Bend Indiana
United States Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi
United States MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - Valley Spokane Valley Washington
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Mercy Medical Center Springfield Massachusetts
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Geisinger Medical Group State College Pennsylvania
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Marshfield Clinic Stevens Point Center Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin
United States Houston Methodist Sugar Land Hospital Sugar Land Texas
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Aurora Medical Center in Summit Summit Wisconsin
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Southwest Illinois Health Services LLP Swansea Illinois
United States Hematology Oncology Associates of Central New York-Onondaga Hill Syracuse New York
United States Mary Bridge Children's Hospital and Health Center Tacoma Washington
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Houston Methodist The Woodlands Hospital The Woodlands Texas
United States Sanford Thief River Falls Medical Center Thief River Falls Minnesota
United States National Jewish Health-Northern Hematology Oncology Thornton Colorado
United States Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas
United States UM Saint Joseph Medical Center Towson Maryland
United States Munson Medical Center Traverse City Michigan
United States Dayton Physicians LLC-Upper Valley Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States Legacy Meridian Park Hospital Tualatin Oregon
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver Washington
United States Legacy Salmon Creek Hospital Vancouver Washington
United States Ridgeview Medical Center Waconia Minnesota
United States Epic Care Cyberknife Center Walnut Creek California
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Saint Joseph Warren Hospital Warren Ohio
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States Illinois CancerCare - Washington Washington Illinois
United States Marion L Shepard Cancer Center at Vidant Beaufort Hospital Washington North Carolina
United States Mercy Hospital Washington Washington Missouri
United States MercyOne Waterloo Medical Center Waterloo Iowa
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States AdventHealth Infusion Center Weaverville Weaverville North Carolina
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States Methodist West Hospital West Des Moines Iowa
United States William E Kahlert Regional Cancer Center/Sinai Hospital Westminster Maryland
United States Marshfield Medical Center - Weston Weston Wisconsin
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Sanford Cancer Center Worthington Worthington Minnesota
United States Fairview Lakes Medical Center Wyoming Minnesota
United States Metro Health Hospital Wyoming Michigan
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States Saint Elizabeth Youngstown Hospital Youngstown Ohio
United States Huron Gastroenterology PC Ypsilanti Michigan
United States IHA Hematology Oncology Consultants-Ann Arbor Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Guam, 

Outcome

Type Measure Description Time frame Safety issue
Primary No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods The specific measure will be based on the proportion of patients with a value of 0, as measured by the single nausea item (scale 0-10, 0 is no symptoms, 10 is worst symptoms) of the Questionnaire. A modified intent-to-treat principle will be applied for statistical analysis of efficacy in evaluable patients. The proportions of patients with no nausea during the overall, the acute, and the delayed period will be summarized by treatment arm. They will be tested in a sequential manner, using a Simes gatekeeping procedure to maintain the overall significance level at the specified by the Lan-DeMets family of alpha spending function. The difference in no nausea proportions between arms will be estimated along with a one-sided 95% confidence interval. The tests and the confidence intervals will be constructed using normal approximation of the binomial distribution adjusted for the non-inferiority margin. Up to 120 hours
Secondary Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire The specific measure will be based on the proportion of patients who answered "None" to both questions concerning Vomiting episode(None, Once, Twice, More than twice) and number of extra nausea/vomiting pills taken (None, One, Two, More than two) in the Nausea and Vomiting Daily Diary/Questionnaire. The CR rate for the overall, the acute, and the delayed period will be summarized by treatment arm and will be compared using a Chi-squared test. The difference in CR rates between arms will be estimated along with a 95% confidence interval. Up to 120 hours
Secondary Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire Potential toxicities includes nausea, undesired sedation, and undesired appetite, measured by three individual items ( nausea, undesired sedation, undesired appetite) of the Nausea and Vomiting Daily Dairy/Questionnaire(scale 0-10, 0 is no symptoms, 10 is worst symptoms). Incidences of toxicities will be summarized by type and by treatment arm. Incidences of toxicities will be compared between arms using a Chi-squared test or the Fisher's exact test as appropriate. In addition, undesired sedation and appetite increase as collected in the Nausea and Vomiting Daily Diary/Questionnaire will be analyzed by repeated measures analyses including descriptive statistics, graphical approaches, and growth curve models to account for the factor of day and time trend. Up to 120 hours
Secondary Average Nausea Scores (0-10) Repeatedly Measured by the Nausea and Vomiting Daily Diary/Questionnaire The specific measure will be based on the by the single nausea item (scale 0-10, 0 is no symptoms, 10 is worst symptoms) of the Nausea and Vomiting Daily Diary/Questionnaire. Nausea scores (0-10) repeatedly measured by the Nausea and Vomiting Daily Diary/Questionnaire will be analyzed using the repeated measures analyses and growth curve models as described above for undesired sedation and increase in appetite. Up to 1 year
Secondary Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire The specific measure will be based on the single item : number of extra nausea/vomiting pills taken (None, One , Twice, More than twice) of the Nausea and Vomiting Daily Diary/Questionnaire. Over 5 Days per each of the 4 cycles
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