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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00499369
Other study ID # NCI-2009-00784
Secondary ID NCI-2009-00784CA
Status Terminated
Phase Phase 3
First received July 10, 2007
Last updated July 25, 2014
Start date June 2007
Est. completion date November 2012

Study information

Verified date March 2014
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This randomized phase III trial is studying giving irinotecan and cetuximab together with bevacizumab to see how well it works compared with giving irinotecan and cetuximab alone in treating patients with metastatic colorectal cancer that progressed during first-line therapy. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether irinotecan and cetuximab are more effective with or without bevacizumab in treating metastatic colorectal cancer.


Description:

PRIMARY OBJECTIVES:

I. Compare progression-free survival of patients with metastatic colorectal cancer that progressed on first-line therapy comprising bevacizumab and FOLFOX, OPTIMOX, or XELOX treated with irinotecan hydrochloride-based chemotherapy and cetuximab with vs without bevacizumab.

II. Compare overall survival of patients treated with these regimens. III. Compare objective tumor response (confirmed and unconfirmed, complete and partial response) in patients with measurable disease treated with these regimens.

IV. Compare the tolerability and safety profile of these regimens in these patients.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to Zubrod performance status (0 vs 1 or 2), discontinuation of oxaliplatin during first-line therapy (yes vs no), planned concurrent chemotherapy (FOLFIRI vs single-agent irinotecan hydrochloride), and time from last dose of bevacizumab (14-42 days vs >= 43 days).

All patients receive 1 of the following chemotherapy regimens:

SINGLE AGENT IRINOTECAN HYDROCHLORIDE: Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

FOLFIRI: Patients receive irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours on days 1 and 2. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Patients are then randomized to 1 of 3 treatment arms.

ARM I: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab as in arm I. Patients also receive bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.

ARM III (closed to accrual as of 4/20/2009): Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab as in arm I. Patients also receive a higher dose of bevacizumab (higher than in arm II) IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for 2 years and then once a year for 3 years.


Recruitment information / eligibility

Status Terminated
Enrollment 72
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must have metastatic colorectal cancer that has been histologically or cytologically confirmed; confirmation may be from either the primary tumor or a metastasis; patients must have wild type KRAS

- Patients must be registered within 28 days of documented disease progression on first line chemotherapy with bevacizumab plus either FOLFOX, OPTIMOX, or XELOX; this progression must have occurred within 90 days after the last dose of bevacizumab; patients who discontinued oxaliplatin, continued with 5-FU/LV or capecitabine and bevacizumab and then had subsequent progression while on fluoropyrimidine and bevacizumab are eligible; patients who discontinued bevacizumab due to adverse events in the first-line setting are not eligible

- Measurable or nonmeasurable disease

- At least 14 days must have elapsed since the last dose of first line chemotherapy and bevacizumab

- Patients must not have received prior treatment with irinotecan (either as adjuvant or metastatic treatment)

- Patients must have no history of prior treatment with cetuximab or other agents targeting VEGF or EGFR (except for bevacizumab)

- Prior radiotherapy is allowed, provided at least 28 days have elapsed since the last treatment; all adverse events related to radiation therapy must be resolved

- Prior surgery is allowed, provided at least 28 days have elapsed since any major surgery and patient has recovered from all effects

- Zubrod performance status 0-2

- Absolute neutrophil count (ANC) >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Hemoglobin >= 9 g/dL

- Total bilirubin =< 1.5 times upper limit of normal (ULN)

- Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate transaminase (SGPT) =< 2.5 x IULN; if there are known liver metastases, SGOT or SGPT must be =< 5 x IULN; these results must be obtained within 28 days prior to registration

- Serum creatinine =< IULN or measured or estimated creatinine clearance >= 60 mL/min

- Patients must not have a history or known presence of brain metastasis

- Patients may be on full dose anticoagulation with warfarin provided that the patient has an acceptable International Normalized Ratio (INR) (between 2 and 3), obtained within 28 days prior to registration

- No clinically relevant bleeding diathesis or coagulopathy

- Patients must not have experienced nephrotic range proteinuria from prior bevacizumab therapy; urine protein must be screened by urine analysis for Urine Protein Creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must be < 1,000 mg for patient enrollment; urine protein and creatinine used in calculating the UPC ratio must be obtained within 28 days prior to registration

- No uncontrolled high blood pressure (BP) (i.e., systolic BP > 150 mm Hg and diastolic BP > 90 mm Hg)

- No cardiovascular event within the past 6 months, including any of the following:

- Arterial thrombosis

- Unstable angina

- Myocardial infarction

- Cerebrovascular accident

- Patients must not have New York Heart Association (NYHA) >= Grade 2 congestive heart failure

- Patients must not have unstable symptomatic arrhythmia requiring medication; (patients with chronic, controlled arrhythmias such as atrial fibrillation or paroxysmal supraventricular tachycardia [PSVT] are eligible)

- No clinically significant peripheral vascular disease

- No serious or nonhealing active wound, ulcer, or bone fracture

- No history of gastrointestinal (GI) perforation while on prior bevacizumab

- No significant bleeding episodes (e.g., hemoptysis or upper or lower GI bleeding) within the past 6 months unless the source of bleeding has been resected

- No known hypersensitivity to bevacizumab or known potential hypersensitivity to cetuximab

- No other concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of anticancer treatment

- Due to the possibility of harm to a fetus or nursing infant from this treatment regimen, patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method

- No other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ

- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

- At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
irinotecan hydrochloride
Given IV
leucovorin calcium
Given IV
fluorouracil
Given IV
Biological:
cetuximab
Given IV
bevacizumab
Given IV

Locations

Country Name City State
United States Bixby Medical Center Adrian Michigan
United States Hickman Cancer Center Adrian Michigan
United States Akron General Medical Center Akron Ohio
United States The Don and Sybil Harrington Cancer Center Amarillo Texas
United States McFarland Clinic PC-William R Bliss Cancer Center Ames Iowa
United States AnMed Health Hospital Anderson South Carolina
United States Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Atlanta Regional CCOP Atlanta Georgia
United States Northside Hospital Atlanta Georgia
United States Piedmont Hospital Atlanta Georgia
United States Saint Joseph's Hospital of Atlanta Atlanta Georgia
United States Sturdy Memorial Hospital Attleboro Massachusetts
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States Well Star Cobb Hospital Austell Georgia
United States Eastern Maine Medical Center Bangor Maine
United States Baton Rouge General Medical Center Baton Rouge Louisiana
United States Mary Rutan Hospital Bellefontaine Ohio
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Hematology Oncology Associates-Quad Cities Bettendorf Iowa
United States Billings Clinic Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies PC Billings Montana
United States Montana Cancer Consortium CCOP Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Bismarck Cancer Center Bismarck North Dakota
United States Mid Dakota Clinic Bismarck North Dakota
United States Saint Alexius Medical Center Bismarck North Dakota
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Saint Joseph Medical Center Bloomington Illinois
United States Boston Medical Center Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States Bozeman Deaconess Hospital Bozeman Montana
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Montefiore Medical Center Bronx New York
United States Veterans Affairs Western New York Health Care System-Buffalo Buffalo New York
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Fairview Ridges Hospital Burnsville Minnesota
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Aultman Health Foundation Canton Ohio
United States Graham Hospital Association Canton Illinois
United States Mercy Medical Center Canton Ohio
United States Southeast Missouri Hospital Cape Girardeau Missouri
United States Memorial Hospital Carthage Illinois
United States Rocky Mountain Oncology Casper Wyoming
United States East Bay Radiation Oncology Center Castro Valley California
United States Eden Hospital Medical Center Castro Valley California
United States Valley Medical Oncology Consultants-Castro Valley Castro Valley California
United States Cedar Rapids Oncology Association Cedar Rapids Iowa
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States West Virginia University Charleston Charleston West Virginia
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Resurrection Healthcare Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Finger Lakes Hematology and Oncology Clifton Springs New York
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States North Coast Cancer Care-Clyde Clyde Ohio
United States Memorial Hospital Colorado Springs Colorado Springs Colorado
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States South Carolina Oncology Associates PA Columbia South Carolina
United States University of Missouri - Ellis Fischel Columbia Missouri
United States Veterans Administration Columbia Missouri
United States Columbus CCOP Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States John B Amos Cancer Center Columbus Georgia
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States Mercy Hospital Coon Rapids Minnesota
United States Bay Area Hospital Coos Bay Oregon
United States Geisinger Medical Center Danville Pennsylvania
United States Mercy Fitzgerald Hospital Darby Pennsylvania
United States Oakwood Hospital Dearborn Michigan
United States Atlanta VA Medical Center Decatur Georgia
United States Decatur Memorial Hospital Decatur Illinois
United States Dekalb Medical Center Decatur Georgia
United States Grady Memorial Hospital Delaware Ohio
United States Colorado Cancer Research Program CCOP Denver Colorado
United States Exempla Saint Joseph Hospital Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rose Medical Center Denver Colorado
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa Oncology Research Association CCOP Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Capitol Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Henry Ford Hospital Detroit Michigan
United States Saint John Hospital and Medical Center Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Bayhealth Medical Center at Kent General Dover Delaware
United States City of Hope Medical Center Duarte California
United States Essentia Health Duluth Clinic CCOP Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Greenville Health System Cancer Institute-Easley Easley South Carolina
United States Memorial Hospital at Easton - Shore Regional Cancer Center Easton Maryland
United States Mayo Clinic Health System Eau Claire Hospital - Luther Campus Eau Claire Wisconsin
United States Midelfort Clinic-Clairemont Campus Eau Claire Wisconsin
United States Fairview-Southdale Hospital Edina Minnesota
United States Crossroads Cancer Center Effingham Illinois
United States Saint Anthony Memorial Hospital Effingham Illinois
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Elkhart Clinic Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology Oncology PC-Elkhart Elkhart Indiana
United States Aurora Cancer Care-Southern Lakes Elkhorn Wisconsin
United States Community Health Partners Regional Medical Center Elyria Ohio
United States Hematology Oncology Center Incorporated Elyria Ohio
United States Swedish Medical Center Englewood Colorado
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Eureka Hospital Eureka Illinois
United States Northbay Cancer Center Fairfield California
United States Etzell, Paul S MD (UIA Investigator) Fergus Falls Minnesota
United States Swenson, Wade II, MD (UIA Investigator) Fergus Falls Minnesota
United States Genesys Regional Medical Center-West Flint Campus Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McLeod Regional Medical Center Florence South Carolina
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Fort Wayne Medical Oncology and Hematology Inc-Parkview Fort Wayne Indiana
United States Frederick Memorial Hospital Frederick Maryland
United States Fredericksburg Oncology Inc Fredericksburg Virginia
United States Fremont Memorial Hospital Fremont Ohio
United States Valley Medical Oncology Consultants-Fremont Fremont California
United States Unity Hospital Fridley Minnesota
United States Saint Edward Mercy Medical Center Ft. Smith Arkansas
United States Galesburg Cottage Hospital Galesburg Illinois
United States Illinois CancerCare Galesburg Galesburg Illinois
United States Glendale Memorial Hospital and Health Center Glendale California
United States Adirondack Cancer Center Glens Falls New York
United States Glens Falls Hospital Glens Falls New York
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Altru Cancer Center Grand Forks North Dakota
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Grand Rapids Clinical Oncology Program Grand Rapids Michigan
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Berdeaux, Donald MD (UIA Investigator) Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin
United States Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin
United States Saint Mary's Hospital Green Bay Wisconsin
United States Saint Vincent Hospital Green Bay Wisconsin
United States Marin General Hospital Greenbrae California
United States Greenville Health System Cancer Institute-Andrews Greenville South Carolina
United States Greenville Health System Cancer Institute-Butternut Greenville South Carolina
United States Greenville Health System Cancer Institute-Faris Greenville South Carolina
United States Greenville Health System Cancer Instutite/Greenville CCOP Greenville South Carolina
United States Greenville Memorial Hospital Greenville South Carolina
United States Self Regional Healthcare Greenwood South Carolina
United States Cancer Centers of the Carolinas-Greer Medical Oncology Greer South Carolina
United States Greenville Health System Cancer Institute-Greer Greer South Carolina
United States Mason District Hospital Havana Illinois
United States Northern Montana Hospital Havre Montana
United States Hays Medical Center Hays Kansas
United States Saint Rose Hospital Hayward California
United States Geisinger Medical Center-Cancer Center Hazelton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Holland Community Hospital Holland Michigan
United States Hopedale Medical Complex - Hospital Hopedale Illinois
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Promise Regional Medical Center-Hutchinson Hutchinson Kansas
United States Cancer Center of Kansas-Independence Independence Kansas
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States Allegiance Health Jackson Michigan
United States Edna Williams Cancer Center at the Baptist Cancer Institute Jacksonville Florida
United States Mayo Clinic in Florida Jacksonville Florida
United States Mercy Health System Janesville Wisconsin
United States Joliet Oncology-Hematology Associates Limited Joliet Illinois
United States Glacier Oncology PLLC Kalispell Montana
United States Kalispell Medical Oncology Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States University of Kansas Medical Center Kansas City Kansas
United States Good Samaritan Hospital Kearney Nebraska
United States Columbia Basin Hematology and Oncology PLLC Kennewick Washington
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Kinston Medical Specialists PA Kinston North Carolina
United States Community Howard Regional Health Kokomo Indiana
United States Adventist La Grange Memorial Hospital La Grange Illinois
United States Indiana University Health La Porte Hospital La Porte Indiana
United States Saint Anthony Hospital Lakewood Colorado
United States Fairfield Medical Center Lancaster Ohio
United States Sparrow Hospital Lansing Michigan
United States Lawrence Memorial Hospital Lawrence Kansas
United States Gwinnett Medical Center Lawrenceville Georgia
United States Central PA Hematology-Medical Oncology Associates PC Lemoyne Pennsylvania
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Lima Memorial Hospital Lima Ohio
United States Nebraska Cancer Research Center Lincoln Nebraska
United States Meeker County Memorial Hospital Litchfield Minnesota
United States Saint Mary Mercy Hospital Livonia Michigan
United States Sky Ridge Medical Center Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States University of Southern California Los Angeles California
United States Doctors Carrol, Sheth, Raghavan Louisville Kentucky
United States McKee Medical Center Loveland Colorado
United States Mcdonough District Hospital Macomb Illinois
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Mayo Clinic Health Systems-Mankato Mankato Minnesota
United States Mansfield General Hospital-MedCentral Health System Mansfield Ohio
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Wellstar Kennestone Hospital Marietta Georgia
United States Bay Area Medical Center Marinette Wisconsin
United States Fremont - Rideout Cancer Center Marysville California
United States Saint Luke's Hospital Maumee Ohio
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio
United States Riddle Hospital Media Pennsylvania
United States University of Tennessee - Memphis Memphis Tennessee
United States Columbia Saint Mary's Hospital - Ozaukee Mequon Wisconsin
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Orange Regional Medical Center Middletown New York
United States Columbia Saint Mary's Water Tower Medical Commons Milwaukee Wisconsin
United States Medical Consultants Limited Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Virginia Piper Cancer Institute Minneapolis Minnesota
United States Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Community Medical Hospital Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Community Cancer Center of Monroe Monroe Michigan
United States Mercy Memorial Hospital Monroe Michigan
United States Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Mount Holly New Jersey
United States Knox Community Hospital Mount Vernon Ohio
United States Skagit Valley Hospital Mount Vernon Washington
United States Mercy Health Partners-Hackley Campus Muskegon Michigan
United States The Hospital of Central Connecticut New Britain Connecticut
United States Licking Memorial Hospital Newark Ohio
United States Cancer Center of Kansas - Newton Newton Kansas
United States Michiana Hematology Oncology PC-Niles Niles Michigan
United States Bromenn Regional Medical Center Normal Illinois
United States Community Cancer Center Foundation Normal Illinois
United States Fisher-Titus Medical Center Norwalk Ohio
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Breast Surgeons Inc Oakland California
United States Bay Area Tumor Institute CCOP Oakland California
United States Highland General Hospital Oakland California
United States Larry G Strieff MD Medical Corporation Oakland California
United States Tom K Lee Inc Oakland California
United States Green Bay Oncology - Oconto Falls Oconto Falls Wisconsin
United States Olathe Cancer Center Olathe Kansas
United States Saint Charles Hospital Oregon Ohio
United States Toledo Clinic Cancer Centers-Oregon Oregon Ohio
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Camden-Clark Memorial Hospital Parkersburg West Virginia
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Singing River Hospital Pascagoula Mississippi
United States Pekin Cancer Treatment Center Pekin Illinois
United States Pekin Hospital Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Illinois Oncology Research Association CCOP Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois Valley Hospital Peru Illinois
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States FirstHealth of the Carolinas-Moore Regional Hosiptal Pinehurst North Carolina
United States Palchak David MD Pismo Beach California
United States Via Christi Hospital-Pittsburg Pittsburg Kansas
United States Allegheny Cancer Center at Allegheny General Hospital Pittsburgh Pennsylvania
United States Valley Care Health System - Pleasanton Pleasanton California
United States Valley Medical Oncology Consultants Pleasanton California
United States Michiana Hematology Oncology PC-Plymouth Plymouth Indiana
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Saint Joseph Mercy Port Huron Port Huron Michigan
United States Adventist Medical Center Portland Oregon
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Perry Memorial Hospital Princeton Illinois
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Rapid City Regional Hospital Rapid City South Dakota
United States Southern Regional Medical Center Riverdale Georgia
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic Rochester Minnesota
United States Harbin Clinic Medical Oncology and Clinical Research Rome Georgia
United States Sutter Roseville Medical Center Roseville California
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Rutherford Hospital Rutherfordton North Carolina
United States UC Davis Comprehensive Cancer Center Sacramento California
United States Saint Mary's of Michigan Saginaw Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Center for Cancer Care and Research Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis University Hospital Saint Louis Missouri
United States Metro-Minnesota CCOP Saint Louis Park Minnesota
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States Saint Joseph's Hospital - Healtheast Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Center of Kansas - Salina Salina Kansas
United States Salina Regional Health Center Salina Kansas
United States Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo California
United States Firelands Regional Medical Center Sandusky Ohio
United States North Coast Cancer Care Sandusky Ohio
United States Hematology and Oncology Associates of North East Pennsylvania Scranton Pennsylvania
United States Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle Washington
United States Group Health Cooperative-Seattle Seattle Washington
United States Harborview Medical Center Seattle Washington
United States Minor and James Medical PLLC Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States The Polyclinic Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States United General Hospital Sedro-Woolley Washington
United States Greenville Health System Cancer Institute-Seneca Seneca South Carolina
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Welch Cancer Center Sheridan Wyoming
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Hematology Oncology Associates Sioux City Iowa
United States Memorial Hospital of South Bend South Bend Indiana
United States Michiana Hematology Oncology PC-South Bend South Bend Indiana
United States Northern Indiana Cancer Research Consortium South Bend Indiana
United States South Bend Clinic South Bend Indiana
United States Sparta Cancer Treatment Center Sparta New Jersey
United States Greenville Health System Cancer Institute-Spartanburg Spartanburg South Carolina
United States Spartanburg Regional Medical Center Spartanburg South Carolina
United States Upstate Carolina CCOP Spartanburg South Carolina
United States Cancer Care Northwest - Spokane South Spokane Washington
United States Evergreen Hematology and Oncology PS Spokane Washington
United States Saint Margaret's Hospital Spring Valley Illinois
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Springfield Regional Medical Center Springfield Ohio
United States Lakeland Hospital St. Joseph Michigan
United States Geisinger Medical Group State College Pennsylvania
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Flower Hospital Sylvania Ohio
United States Scott and White Memorial Hospital Temple Texas
United States North Suburban Medical Center Thornton Colorado
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Space Coast Cancer Centers-Titusville Titusville Florida
United States Mercy Saint Anne Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States The Toledo Hospital/Toledo Children's Hospital Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Toledo Community Hospital Oncology Program CCOP Toledo Ohio
United States University of Toledo Toledo Ohio
United States Saint Francis Hospital and Medical Center - Topeka Topeka Kansas
United States Stormont-Vail Regional Health Center Topeka Kansas
United States Tahoe Forest Cancer Center Truckee California
United States Associates In Hematology Oncology PC-Upland Upland Pennsylvania
United States Carle Cancer Center Urbana Illinois
United States Carle Clinic-Urbana Main Urbana Illinois
United States South Georgia Medical Center Valdosta Georgia
United States Virtua West Jersey Hospital Voorhees Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Lombardi Comprehensive Cancer Center at Georgetown University Washington District of Columbia
United States Covenant Medical Center Waterloo Iowa
United States Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Wenatchee Valley Medical Center Wenatchee Washington
United States Saint Ann's Hospital Westerville Ohio
United States Michiana Hematology Oncology-PC Westville Westville Indiana
United States Exempla Lutheran Medical Center Wheat Ridge Colorado
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Main Office Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Via Christi Regional Medical Center Wichita Kansas
United States Wichita CCOP Wichita Kansas
United States Geisinger Wyoming Valley Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Minnesota Oncology and Hematology PA-Woodbury Woodbury Minnesota
United States Woodwinds Health Campus Woodbury Minnesota
United States Genesis HealthCare System Zanesville Ohio

Sponsors (5)

Lead Sponsor Collaborator
National Cancer Institute (NCI) Canadian Cancer Trials Group, Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, North Central Cancer Treatment Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival (PFS) PFS is measured from date of registration to first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Up to 5 years No
Secondary Overall Survival Time to death is from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. Up to 5 years No
Secondary Objective Tumor Response Up to 5 years No
Secondary Toxicity Number of patients with Grade 3 through 5 adverse events that are related to study drug. Only adverse events that are possibly, probably or definitely related to study drug are reported. Up to 5 years Yes
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