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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00977574
Other study ID # NCI-2011-01969
Secondary ID NCI-2011-01969GO
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 14, 2009
Est. completion date March 6, 2025

Study information

Verified date March 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase II trial studies paclitaxel, carboplatin, and bevacizumab or paclitaxel, carboplatin, and temsirolimus or ixabepilone, carboplatin, and bevacizumab to see how well they work in treating patients with stage III, stage IV, or recurrent endometrial cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ixabepilone, 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 bevacizumab, may interfere with the ability of tumor cells to grow and spread. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known which treatment regimen is most effective in treating patients with endometrial cancer.


Description:

PRIMARY OBJECTIVES: I. To estimate the hazard of progression or death of each of the three arms relative to that of historical controls in patients with advanced or recurrent endometrial cancer. SECONDARY OBJECTIVES: I. To determine the nature, frequency, and maximum degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v)3.0 for each of the three arms. II. To estimate the distribution of the duration of overall survival for each of the three arms. III. To estimate the proportion of patients with measurable disease who have confirmed objective tumor responses by treatment. TERTIARY OBJECTIVES: I. Explore the associations between select biomarkers and progression-free survival as well as secondary measures of clinical outcome (overall survival, tumor response, or disease status if possible) in the context of histologic cell type and treatment. IA. Somatic mutations in phosphatase and tensin homolog (PTEN)/ phosphoinositide-3-kinase (PI3K) and RAS pathway members by Sequenom mutational profiling and targeted sequencing of candidate genes. IB. Microsatellite instability by analysis of five National Cancer Institute consensus microsatellite markers (BAT25, BAT26, D2S2123, D5S346, and D17S250) using the Applied Biosystems (ABI) Prism 3100 Genetic Analyzer. IC. Copy number alterations (gains or losses) by array comparative genomic hybridization (aCGH). ID. Tumor expression of PTEN and class III beta-tubulin using immunohistochemistry. IE. Concentration of vascular endothelial growth factor (VEGF) in pre-cycle 1 plasma using an enzyme-linked immunosorbent assay. II. Explore the relationship among the various biomarkers by histologic subtype and treatment. III. Explore which combination of biomarkers and clinical covariates optimally predicts responsiveness and resistance to the three treatment arms. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours, carboplatin IV over 30 minutes, and bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: *Patients undergoing treatment post-surgery (=< 12 weeks) receive bevacizumab beginning on course 2. ARM II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and temsirolimus* IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive temsirolimus IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: *Patients undergoing treatment post-surgery (=< 12 weeks) receive temsirolimus beginning on course 2. ARM III: Patients receive ixabepilone IV over 1 hour, carboplatin IV over 30 minutes, and bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: *Patients undergoing treatment post-surgery (=< 12 weeks) receive bevacizumab beginning on course 2. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 349
Est. completion date March 6, 2025
Est. primary completion date January 31, 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients must have measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma - Histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma - Measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI - Patients must have Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 - Patients must not be eligible for a higher priority GOG protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population - Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl equivalent to Common Terminology Criteria (CTCAE v3.0) grade 1 - Platelets greater than or equal to 100,000/mcl - Creatinine less than or equal to 1.5 times institutional upper limit normal (ULN), CTCAE v3.0 grade 1 - Bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1) - Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1) - Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1) - Urine protein creatinine (UPC) ratio must be < 1.0 gram (gm); if UPC ratio >= 1, collection of 24-hour urine measurement of urine protein is recommended (24-hour urine protein level must be < 1000 mg for patient enrollment) - UPC ratio of spot urine is an estimation of the 24 urine protein excretion - A UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm - Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) =< 1.5 x ULN - Fasting cholesterol less than 300 mg/dL (CTCAE v3.0 grade 1) - Fasting triglycerides =< 2.5 x ULN (CTCAE v3.0 grade 1) - Patients must NOT have received prior chemotherapy or targeted therapy, including chemotherapy used for radiation sensitization for treatment of endometrial carcinoma - Patients must NOT have received prior therapy with bevacizumab or other VEGF pathway targeted therapy; patients must NOT have received prior therapy with temsirolimus, everolimus, ridaforolimus, sirolimus, or any other PI3K/ v-akt murine thymoma viral oncogene homolog 1 (AKT)/mammalian target of rapamycins (mTor) pathway targeted therapy - Patients may have receive prior radiation therapy for treatment of endometrial carcinoma; prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy; all radiation therapy must be completed at least 4 weeks prior to the first date of study therapy; the prior radiation field, radiation dose, number of fractions and prior radiation start and stop dates must be provided on the Fast Fact Sheet (FFS) at registration - Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapy - Patients must have signed an approved informed consent and authorization permitting release of personal health information Exclusion Criteria: - Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, and other specific malignancies as noted below, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy - Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease - Patients who have received prior chemotherapy for any abdominal or pelvic tumor within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease - Patients with serious, non-healing wound, ulcer, or bone fracture; this includes history of abdominal/pelvic fistula, gastrointestinal perforation or intra-abdominal abscess within 3 months prior to the first date of study therapy; patients with underlying lesions that caused the fistula or perforation in the past that have not been corrected - Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels - Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy or any brain metastases - Patients with clinically significant cardiovascular disease; this includes: - Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg - Myocardial infarction or unstable angina within 6 months of the first date of study therapy - New York Heart Association (NYHA) class II or greater congestive heart failure - History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication) - CTCAE grade 2 or greater peripheral vascular disease. - History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of study therapy. - Aortic aneurysm and/or history of aortic dissection - Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies - Patients undergoing invasive procedures as defined below: - Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab or temsirolimus therapy - Major surgical procedure anticipated during the course of the study. - Minor surgical procedures, fine needle aspirates, or core biopsies within 7 days prior to the first date of study therapy - Patients with known prior history of interstitial pneumonitis - Patients with CTCAE v. 3, grade 2 or greater hypoxemia - Patients with CTCAE v. 3, grade 2 or greater dyspnea - Patients must not have uncontrolled diabetes, and must not have baseline hemoglobin A1C (HgbA1C) > 8 - Patients with peripheral neuropathy > CTCAE v.3, grade 1 - Patients who are pregnant or nursing

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Bevacizumab
Given IV
Drug:
Carboplatin
Given IV
Ixabepilone
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies
Drug:
Paclitaxel
Given IV
Temsirolimus
Given IV

Locations

Country Name City State
United States Pali Momi Medical Center 'Aiea Hawaii
United States Jefferson Abington Hospital Abington Pennsylvania
United States Cleveland Clinic Akron General Akron Ohio
United States Summa Health System - Akron Campus Akron Ohio
United States Women's Cancer Care Associates LLC Albany New York
United States Southwest Gynecologic Oncology Associates Inc Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States McFarland Clinic - Ames Ames Iowa
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States Hope Women's Cancer Centers-Asheville Asheville North Carolina
United States UCHealth University of Colorado Hospital Aurora Colorado
United States Greater Baltimore Medical Center Baltimore Maryland
United States MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States PeaceHealth Medical Group PC Bellingham Washington
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Island Gynecologic Oncology Brightwaters New York
United States State University of New York Downstate Medical Center Brooklyn New York
United States Roswell Park Cancer Institute Buffalo New York
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Cone Health Cancer Center at Alamance Regional Burlington North Carolina
United States University of Vermont Medical Center Burlington Vermont
United States Cooper Hospital University Medical Center Camden New Jersey
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States Medical University of South Carolina Charleston South Carolina
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States University of Virginia Cancer Center Charlottesville Virginia
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
United States Morton Plant Hospital Clearwater Florida
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Mission Cancer and Blood - West Des Moines Clive Iowa
United States MU Health - University Hospital/Ellis Fischel Cancer Center Columbia Missouri
United States South Carolina Oncology Associates PA Columbia South Carolina
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States John Muir Medical Center-Concord Concord California
United States Clements University Hospital Dallas Texas
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States Miami Valley Hospital Dayton Ohio
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Duke University Medical Center Durham North Carolina
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Advocate Sherman Hospital Elgin Illinois
United States Elkhart Clinic Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology Oncology PC-Elkhart Elkhart Indiana
United States Christiana Care - Union Hospital Elkton Maryland
United States Rocky Mountain Gynecologic Oncology PC Englewood Colorado
United States Providence Regional Cancer Partnership Everett Washington
United States Genesys Regional Medical Center-West Flint Campus Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States New York Hospital Medical Center of Queens Fresh Meadows New York
United States University of Texas Medical Branch Galveston Texas
United States Virginia Oncology Associates-Hampton Hampton Virginia
United States Hartford Hospital Hartford Connecticut
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Hinsdale Hematology Oncology Associates Incorporated Hinsdale Illinois
United States Sudarshan K Sharma MD Limited-Gynecologic Oncology Hinsdale Illinois
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children 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 University of Hawaii Cancer Center Honolulu Hawaii
United States Lyndon Baines Johnson General Hospital Houston Texas
United States M D Anderson Cancer Center Houston Texas
United States Cancer Center of Kansas-Independence Independence Kansas
United States Ascension Saint Vincent Indianapolis Hospital Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Allegiance Health Jackson Michigan
United States Saint Dominic-Jackson Memorial Hospital Jackson Mississippi
United States University of Mississippi Medical Center Jackson Mississippi
United States Mayo Clinic in Florida Jacksonville Florida
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States University of Kansas Cancer Center Kansas City Kansas
United States Kettering Medical Center Kettering Ohio
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Community Howard Regional Health Kokomo Indiana
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States UC San Diego Moores Cancer Center La Jolla California
United States IU Health La Porte Hospital La Porte Indiana
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Beebe Medical Center Lewes Delaware
United States Baptist Health Lexington Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California
United States The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States Central Georgia Gynecologic Oncology Macon Georgia
United States University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Morristown Medical Center Morristown New Jersey
United States Virtua Memorial Mount Holly New Jersey
United States Skagit Regional Health Cancer Care Center Mount Vernon Washington
United States Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States The Hospital of Central Connecticut New Britain Connecticut
United States Yale University New Haven Connecticut
United States Memorial Sloan Kettering Cancer Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Rutgers New Jersey Medical School Newark New Jersey
United States Cancer Center of Kansas - Newton Newton Kansas
United States Corewell Health Lakeland Hospitals - Niles Hospital Niles Michigan
United States Virginia Oncology Associates - Norfolk Norfolk Virginia
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Methodist Hospital Omaha Nebraska
United States AdventHealth Orlando Orlando Florida
United States Orlando Health Cancer Institute Orlando Florida
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Singing River Hospital Pascagoula Mississippi
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Pennsylvania Hospital Philadelphia Pennsylvania
United States Saint Luke's Hospital-Warren Campus Phillipsburg New Jersey
United States Saint Joseph's Hospital and Medical Center Phoenix Arizona
United States Michiana Hematology Oncology PC-Plymouth Plymouth Indiana
United States Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Maine Medical Center-Bramhall Campus Portland Maine
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Women and Infants Hospital Providence Rhode Island
United States Center of Hope at Renown Medical Center Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Carilion Clinic Gynecological Oncology Roanoke Virginia
United States Mayo Clinic in Rochester Rochester Minnesota
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph Michigan
United States Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph Michigan
United States SSM Health Saint Louis University Hospital Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Cancer Center of Kansas - Salina Salina Kansas
United States San Diego VA Medical Center San Diego California
United States UC San Diego Medical Center - Hillcrest San Diego California
United States UCSF Medical Center-Mount Zion San Francisco California
United States Memorial Health University Medical Center Savannah Georgia
United States Mayo Clinic in Arizona Scottsdale Arizona
United States FHCC South Lake Union Seattle Washington
United States Fred Hutchinson Cancer Center Seattle Washington
United States Kaiser Permanente Washington Seattle Washington
United States Pacific Gynecology Specialists Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States University of Washington Medical Center - Montlake Seattle Washington
United States University of Washington Medical Center - Northwest Seattle Washington
United States Olympic Medical Cancer Care Center Sequim Washington
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Saint Michael Cancer Center Silverdale Washington
United States Avera Cancer Institute Sioux Falls South Dakota
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 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 Cancer Care Northwest - Spokane South Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane Washington
United States Baystate Medical Center Springfield Massachusetts
United States Cancer Research for the Ozarks NCORP Springfield Missouri
United States CoxHealth South Hospital Springfield Missouri
United States Mercy Hospital Springfield Springfield Missouri
United States Geisinger Medical Group State College Pennsylvania
United States Stony Brook University Medical Center Stony Brook New York
United States Overlook Hospital Summit New Jersey
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Saint Joseph Medical Center Tacoma Washington
United States Scott and White Memorial Hospital Temple Texas
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Virtua Voorhees Voorhees New Jersey
United States Maui Memorial Medical Center Wailuku Hawaii
United States Pacific Cancer Institute of Maui Wailuku Hawaii
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States John Muir Medical Center-Walnut Creek Walnut Creek California
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States MedStar Washington Hospital Center Washington District of Columbia
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Wenatchee Valley Hospital and Clinics Wenatchee Washington
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Methodist West Hospital West Des Moines Iowa
United States Reading Hospital West Reading Pennsylvania
United States Michiana Hematology Oncology PC-Westville Westville Indiana
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 Wichita NCI Community Oncology Research Program Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States UMass Memorial Medical Center - Memorial Division Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
National Cancer Institute (NCI) NRG Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Who Progressed or Died by 25 Months From Enrollment PFS (Progression free survival) is defined as the duration of time from date of study entry to time of progression or death, whichever occurs first. Patients with a status of alive, progression-free are censored at their date of last follow-up. To lessen the potential for bias in the progression evaluation times between treatment arms and historical controls, progression/death times will be grouped over 6 18-week time intervals. Progressions are carried forward to the end of the interval. All progressions or deaths occurring after the 6th 18-week interval are censored at 25 months for this analysis. Study NCT00977574 at 25 months
Secondary Frequency and Severity of Toxicity as Assessed by CTCAE v3.0 for Each of the Three Arms. Median of 10 cycles of treatment plus 30 days
Secondary The Median Duration of Overall Survival for Each of the Three Arms. Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. Time from date of study entry to time of death or the date of last contact, assessed up to 5 years
Secondary The Proportion of Patients With Measurable Disease Who Have Confirmed Objective Tumor Responses by Treatment. RECIST 1.1 was used to define objective tumor response. A complete response is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. A partial response is defined as At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. There can be no unequivocal progression of non-target lesions and no new lesions. Complete and partial responses are included in the objective tumor response rate. Confirmation of response was not required. Imaging was done every 3 cycles and at any other time clinically indicated. Imaging was required every 9 weeks until progression or initiation on non protocol therapy. After 2 years of protocol therapy or follow up, CT scan or MRI was every 3 months
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