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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01081262
Other study ID # NCI-2011-02516
Secondary ID NCI-2011-02516GO
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date October 12, 2010
Est. completion date March 1, 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 III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, 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 block tumor growth in different ways by targeting certain cells. It is not yet known which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.


Description:

PRIMARY OBJECTIVES: I. To determine if capecitabine and oxaliplatin reduces the death rate compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube. II. To determine if bevacizumab reduces the death rate compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube. SECONDARY OBJECTIVES: I. To determine if capecitabine and oxaliplatin increases the duration of progression-free survival (PFS) compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube. II. To determine if bevacizumab increases the duration of PFS compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube. III. To compare the response rates for capecitabine and oxaliplatin versus carboplatin and paclitaxel in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery. IV. To compare the response rates for bevacizumab versus no bevacizumab in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery. V. To determine the nature and degree of toxicity of capecitabine and oxaliplatin compared with that of carboplatin and paclitaxel in this cohort of patients. VI. To determine the nature and degree of toxicity of bevacizumab in this cohort of patients. VII. To compare capecitabine and oxaliplatin versus carboplatin and paclitaxel with respect to changes in patient reported neurotoxicity. VIII. To determine the impact on quality of life (QOL, as measured by the Functional Assessment of Cancer Therapy-Ovarian [FACT-O] Trial Outcome Index [TOI]) following treatment with the above regimens. TERTIARY OBJECTIVES: I. To collect fixed and/or frozen tissue and whole blood for future research studies. OUTLINE: Patients are randomized to 1 of 4 treatment arms. ARM I: Patients receive carboplatin intravenously (IV) over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. ARM III: Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. ARM IV: Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III. After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date March 1, 2025
Est. primary completion date February 25, 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with a histologic diagnosis of mucinous adenocarcinoma of the ovary or fallopian tube with either optimal (=< 1 cm residual disease) or suboptimal residual disease following initial surgery; patients may have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or no measurable disease - All patients must have had appropriate surgery including appendectomy (unless patient has history of prior appendectomy) for ovarian or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage - Patients must have stage II-IV disease (new or recurrent-chemonaïve; no brain metastasis) or recurrent stage I disease (chemonaïve) - Newly diagnosed patients must begin protocol therapy within 10 weeks of primary debulking; for stage I recurrent patients (chemonaïve), they should begin protocol therapy within 14 days of randomization - Patients must have a negative colonoscopy within 1 year of enrolling in the study - Absolute neutrophil count (ANC) >= 1,500/mcl - White blood cell (WBC) count >= 3,000/mcl - Platelets >= 100,000/mcl - Hemoglobin (Hgb) >= 10 g/dl (can be post transfusion) - Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN) OR creatinine clearance > 50 cc/min - Bilirubin =< 1.5 x ULN - Serum glutamic oxaloacetic transaminase (SGOT) =< to 2.5 x ULN - Alkaline phosphatase =< to 2.5 x ULN - Neuropathy (sensory and motor) =< Common Terminology Criteria for Adverse Events (CTCAE) grade 1 - Urine dipstick for proteinuria < 2+; if urine dipstick is >= 2+, 24 hour urine must demonstrate =< 1 g protein in 24 hours OR patients must have a urine protein-to-creatinine ratio (UPCR) < 1.0 mg/dL - Prothrombin time (PT) =< 1.5 x ULN - Activated prothrombin time (APTT) =< 1.5 x ULN - Patients of childbearing potential must agree to practice an effective form of birth control during study treatment and for six months after completion of treatment - Patients who have met the pre-entry requirements - Patients must have signed an approved informed consent and authorization permitting release of personal health information - Patients with Gynecologic Oncology Group (GOG) performance grade of 0, 1 or 2 - Patients with life expectancy > 3 months Exclusion Criteria: - Patients with known colon cancer or history of colon cancer - Patients with primary peritoneal carcinoma - Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy - Patients who have received chemotherapy, radiotherapy or any investigational treatment for a gynecologic cancer (does include breast cancer) or colorectal cancer prior to enrollment - Patients with a major surgical procedure anticipated during the course of the study; this includes but is not limited to: abdominal surgery (laparotomy or laparoscopy) such as colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery; please consult with the study chair prior to patient entry for any questions related to the classification of surgical procedures - Patients may have minor surgical procedures (i.e., mediport insertion) fine needle aspiration or core biopsies as long as it is performed > 7 days prior to the first date of bevacizumab therapy and there is no evidence of wound disruption or impaired healing - Patients with surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for fact that bevacizumab can be omitted from first cycle of chemotherapy) - Patients with a history of abdominal fistula or perforation within the past 12 months - Patients with a current, serious, non-healing wound, ulcer, or bone fracture; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations - Patients with known hypersensitivity to Chinese hamster cell products or other recombinant human or humanized antibodies - Patients with mixed epithelial ovarian cancer histology - Patients with tumors of low malignant potential - History or evidence of upon physical examination of central nervous system (CNS) disease, including history of primary brain tumor or any history of brain metastases, or seizures not controlled with standard medical therapy - Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 100 mm Hg; patients with a history of hypertension are permitted - Myocardial infarction or unstable angina within 12 months of the first date of bevacizumab therapy - New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication; women who have received prior treatment with anthracycline (including doxorubicin and/or liposomal doxorubicin) and have an ejection fraction < 50% will be excluded from the study - Grade 1, category 2 or greater, peripheral vascular disease; patient cannot have anything worse than mild, symptomatic claudication with exercise - History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of bevacizumab therapy - History of pulmonary embolism or deep vein thrombosis in the past 6 months - Previous history of malabsorption or other conditions preventing oral treatment - Patients who are pregnant or nursing - Patients with acute hepatitis or active infection that requires parenteral antibiotics - Patients with active bleeding or pathologic conditions that carry a high risk of bleeding such as a known bleeding disorder, coagulopathy or tumor involving the major vessels - Patients taking warfarin

Study Design


Related Conditions & MeSH terms

  • Borderline Ovarian Mucinous Tumor
  • Carcinoma
  • Carcinoma, Ovarian Epithelial
  • Cystadenocarcinoma
  • Fallopian Tube Neoplasms
  • Ovarian Mucinous Cystadenocarcinoma
  • Ovarian Neoplasms
  • Recurrence
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Stage IA Fallopian Tube Cancer AJCC v6 and v7
  • Stage IA Ovarian Cancer AJCC v6 and v7
  • Stage IB Fallopian Tube Cancer AJCC v6 and v7
  • Stage IB Ovarian Cancer AJCC v6 and v7
  • Stage IC Fallopian Tube Cancer AJCC v6 and v7
  • Stage IC Ovarian Cancer AJCC v6 and v7
  • Stage IIA Fallopian Tube Cancer AJCC v6 and v7
  • Stage IIA Ovarian Cancer AJCC V6 and v7
  • Stage IIB Fallopian Tube Cancer AJCC v6 and v7
  • Stage IIB Ovarian Cancer AJCC v6 and v7
  • Stage IIC Fallopian Tube Cancer AJCC v6 and v7
  • Stage IIC Ovarian Cancer AJCC v6 and v7
  • Stage IIIA Fallopian Tube Cancer AJCC v7
  • Stage IIIA Ovarian Cancer AJCC v6 and v7
  • Stage IIIB Fallopian Tube Cancer AJCC v7
  • Stage IIIB Ovarian Cancer AJCC v6 and v7
  • Stage IIIC Fallopian Tube Cancer AJCC v7
  • Stage IIIC Ovarian Cancer AJCC v6 and v7
  • Stage IV Fallopian Tube Cancer AJCC v6 and v7
  • Stage IV Ovarian Cancer AJCC v6 and v7

Intervention

Biological:
Bevacizumab
Given IV
Drug:
Capecitabine
Given PO
Carboplatin
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies
Drug:
Oxaliplatin
Given IV
Paclitaxel
Given IV
Other:
Quality-of-Life Assessment
Ancillary studies

Locations

Country Name City State
United States Jefferson Abington Hospital Abington Pennsylvania
United States Summa Health System - Akron Campus Akron Ohio
United States Southwest Gynecologic Oncology Associates Inc Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States AnMed Health Cancer Center Anderson South Carolina
United States AnMed Health Hospital Anderson South Carolina
United States Augusta University Medical Center Augusta Georgia
United States The Medical Center of Aurora Aurora Colorado
United States UCHealth University of Colorado Hospital Aurora Colorado
United States Greater Baltimore Medical Center Baltimore Maryland
United States Mary Rutan Hospital Bellefontaine Ohio
United States Walter Reed National Military Medical Center Bethesda Maryland
United States Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania
United States Billings Clinic Cancer Center Billings Montana
United States Montana Cancer Consortium NCORP 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 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 Illinois CancerCare-Bloomington Bloomington Illinois
United States OSF Saint Joseph Medical Center Bloomington Illinois
United States Boulder Community Hospital Boulder Colorado
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Cooper Hospital University Medical Center Camden New Jersey
United States Aultman Health Foundation Canton Ohio
United States Graham Hospital Association Canton Illinois
United States Illinois CancerCare-Canton Canton Illinois
United States Southeast Cancer Center Cape Girardeau Missouri
United States Illinois CancerCare-Carthage Carthage Illinois
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 Valley Medical Oncology Consultants-Castro Valley Castro Valley California
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
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 Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Columbus NCI Community Oncology Research Program 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 East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Danville Regional Medical Center Danville Virginia
United States Geisinger Medical Center Danville Pennsylvania
United States Heartland Cancer Research NCORP Decatur Illinois
United States Grady Memorial Hospital Delaware Ohio
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 SCL Health Saint Joseph Hospital Denver Colorado
United States Western States Cancer Research NCORP Denver Colorado
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 Duke University Medical Center Durham North Carolina
United States Saint Elizabeth Healthcare Edgewood Edgewood Kentucky
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 Bay Area Breast Surgeons Inc Emeryville California
United States Epic Care Partners in Cancer Care Emeryville California
United States Swedish Medical Center Englewood Colorado
United States OSF Saint Francis Hospital and Medical Group Escanaba Michigan
United States Eureka Hospital Eureka Illinois
United States Illinois CancerCare-Eureka Eureka Illinois
United States Poudre Valley Hospital Fort Collins Colorado
United States Hematology Oncology Associates of Fredericksburg Inc Fredericksburg Virginia
United States Valley Medical Oncology Consultants-Fremont Fremont California
United States Northeast Georgia Medical Center-Gainesville Gainesville Georgia
United States University of Florida Health Science Center - Gainesville Gainesville Florida
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States University of Texas Medical Branch Galveston Texas
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Banner 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 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 Saint Francis Hospital Greenville South Carolina
United States Hartford Hospital Hartford Connecticut
United States Illinois CancerCare-Havana Havana Illinois
United States Mason District Hospital Havana Illinois
United States Northern Montana Hospital Havre Montana
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States AdventHealth Hendersonville Hendersonville North Carolina
United States Sudarshan K Sharma MD Limited-Gynecologic Oncology Hinsdale Illinois
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Houston Methodist Hospital Houston Texas
United States M D Anderson Cancer Center Houston Texas
United States Memorial Hermann Texas Medical Center Houston Texas
United States Ascension Saint Vincent Indianapolis Hospital Indianapolis Indiana
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States MU Health Care Goldschmidt Cancer Center Jefferson City Missouri
United States NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Glacier Oncology PLLC Kalispell Montana
United States Kalispell Medical Oncology Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States University of Tennessee - Knoxville Knoxville Tennessee
United States Community Howard Regional Health Kokomo Indiana
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States IU Health La Porte Hospital La Porte Indiana
United States Cancer Center of Acadiana Lafayette Louisiana
United States Saint Anthony Hospital Lakewood Colorado
United States Fairfield Medical Center Lancaster Ohio
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States Beebe Medical Center Lewes Delaware
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Littleton Adventist Hospital Littleton Colorado
United States Sky Ridge Medical Center Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States Los Angeles General Medical Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Banner McKee Medical Center Loveland Colorado
United States Centra Alan B Pearson Regional Cancer Center Lynchburg Virginia
United States Illinois CancerCare-Macomb Macomb Illinois
United States Mcdonough District Hospital Macomb Illinois
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Marietta Memorial Hospital Marietta Ohio
United States Bay Area Medical Center Marinette Wisconsin
United States Contra Costa Regional Medical Center Martinez California
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
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 Cancer Care Partners LLC Mishawaka Indiana
United States Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States University of South Alabama Mitchell Cancer Institute Mobile Alabama
United States Holy Family Medical Center Monmouth Illinois
United States Illinois CancerCare-Monmouth Monmouth Illinois
United States Virtua Memorial Mount Holly New Jersey
United States Knox Community Hospital Mount Vernon Ohio
United States El Camino Hospital Mountain View California
United States The Hospital of Central Connecticut New Britain Connecticut
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Corewell Health Lakeland Hospitals - Niles Hospital Niles Michigan
United States Bromenn Regional Medical Center Normal Illinois
United States Carle Cancer Institute Normal Normal Illinois
United States Illinois CancerCare-Community Cancer Center Normal Illinois
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Tumor Institute Oakland California
United States Hematology and Oncology Associates-Oakland Oakland California
United States Highland General Hospital Oakland California
United States Tom K Lee Inc Oakland California
United States Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Methodist Hospital Omaha Nebraska
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States AdventHealth Orlando Orlando Florida
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Parker Adventist Hospital Parker Colorado
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Pekin Illinois
United States Illinois CancerCare-Peoria 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 CancerCare-Peru Peru Illinois
United States Illinois Valley Hospital Peru Illinois
United States Saint Joseph's Hospital and Medical Center Phoenix Arizona
United States Pikeville Medical Center Pikeville Kentucky
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States Michiana Hematology Oncology PC-Plymouth Plymouth Indiana
United States Southern Ohio Medical Center Portsmouth Ohio
United States Illinois CancerCare-Princeton Princeton Illinois
United States Perry Memorial Hospital Princeton Illinois
United States Women and Infants Hospital Providence Rhode Island
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Swedish American Hospital Rockford Illinois
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 Missouri Baptist Medical Center Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
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 Regional Cancer Center Sioux City Iowa
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 Spartanburg Medical Center Spartanburg South Carolina
United States Illinois CancerCare-Spring Valley Spring Valley Illinois
United States Baystate Medical Center Springfield Massachusetts
United States Springfield Regional Medical Center Springfield Ohio
United States Stamford Hospital/Bennett Cancer Center Stamford Connecticut
United States Geisinger Medical Group State College Pennsylvania
United States Stony Brook University Medical Center Stony Brook New York
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Aurora Medical Center in Summit Summit Wisconsin
United States Olive View-University of California Los Angeles Medical Center Sylmar California
United States State University of New York Upstate Medical University Syracuse New York
United States North Suburban Medical Center Thornton Colorado
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Virtua Voorhees Voorhees New Jersey
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 Saint Ann's Hospital Westerville Ohio
United States Michiana Hematology Oncology PC-Westville Westville Indiana
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Southeast Clinical Oncology Research Consortium NCORP Winston-Salem North Carolina
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

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
Other Numbers and Percentages of Patients With Mutations in the Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Oncogene Will be tabulated. Interactions between the mutational status of the KRAS oncogene and treatment will be examined. Baseline
Primary Overall Survival Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact. Up to five years
Secondary Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 Grade 1 or higher non-serious adverse events were graded by CTC AE v 4. Every cycle while on treatment, up to 5 years
Secondary Progression-free Survival Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.
Secondary Objective Tumor Response Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),.>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression, and any other time clinically indicated, up to 5 years
Secondary Patient Reported Neurotoxicity Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity. baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
Secondary Patient Reported Quality of Life Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. The FACT-O TOI score ranges 0-100 with a large score suggests better QOL baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
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