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Brief Title: Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer
Official Title: A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients With Mucinous Epithelial Ovarian or Fallopian Tube Cancer (MEOC)
Study ID: NCT01081262
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States
Saint Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro, Arkansas, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States
East Bay Radiation Oncology Center, Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley, Castro Valley, California, United States
Bay Area Breast Surgeons Inc, Emeryville, California, United States
Epic Care Partners in Cancer Care, Emeryville, California, United States
Valley Medical Oncology Consultants-Fremont, Fremont, California, United States
Los Angeles General Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Contra Costa Regional Medical Center, Martinez, California, United States
El Camino Hospital, Mountain View, California, United States
Highland General Hospital, Oakland, California, 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
Tom K Lee Inc, Oakland, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
Doctors Medical Center- JC Robinson Regional Cancer Center, San Pablo, California, United States
Olive View-University of California Los Angeles Medical Center, Sylmar, California, United States
The Medical Center of Aurora, Aurora, Colorado, United States
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States
SCL Health Saint Joseph Hospital, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
Western States Cancer Research NCORP, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Poudre Valley Hospital, Fort Collins, Colorado, United States
Saint Mary's Hospital and Regional Medical Center, Grand Junction, Colorado, United States
Banner North Colorado Medical Center, Greeley, Colorado, United States
Saint Anthony Hospital, Lakewood, Colorado, 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
Banner McKee Medical Center, Loveland, Colorado, United States
Parker Adventist Hospital, Parker, Colorado, United States
Saint Mary Corwin Medical Center, Pueblo, Colorado, United States
North Suburban Medical Center, Thornton, Colorado, United States
SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, United States
Hartford Hospital, Hartford, Connecticut, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Stamford Hospital/Bennett Cancer Center, Stamford, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
AdventHealth Orlando, Orlando, Florida, United States
Augusta University Medical Center, Augusta, Georgia, United States
John B Amos Cancer Center, Columbus, Georgia, United States
Northeast Georgia Medical Center-Gainesville, Gainesville, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia, United States
Queen's Medical Center, Honolulu, Hawaii, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
OSF Saint Joseph Medical Center, Bloomington, Illinois, United States
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Graham Hospital Association, Canton, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Illinois CancerCare-Carthage, Carthage, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Heartland Cancer Research NCORP, Decatur, Illinois, United States
Eureka Hospital, Eureka, Illinois, United States
Illinois CancerCare-Eureka, Eureka, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Illinois CancerCare-Havana, Havana, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology, Hinsdale, Illinois, United States
Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States
Illinois CancerCare-Macomb, Macomb, Illinois, United States
Mcdonough District Hospital, Macomb, Illinois, United States
Holy Family Medical Center, Monmouth, Illinois, United States
Illinois CancerCare-Monmouth, Monmouth, Illinois, 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
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin, Pekin, Illinois, United States
Proctor Hospital, Peoria, 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
Illinois CancerCare-Peru, Peru, Illinois, United States
Illinois Valley Hospital, Peru, Illinois, United States
Illinois CancerCare-Princeton, Princeton, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
Swedish American Hospital, Rockford, Illinois, United States
Illinois CancerCare-Spring Valley, Spring Valley, Illinois, United States
Elkhart Clinic, Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Elkhart, Elkhart, Indiana, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Ascension Saint Vincent Indianapolis Hospital, Indianapolis, Indiana, United States
Community Howard Regional Health, Kokomo, Indiana, United States
IU Health La Porte Hospital, La Porte, Indiana, 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
Michiana Hematology Oncology PC-Plymouth, Plymouth, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend, South Bend, Indiana, United States
South Bend Clinic, South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Michiana Hematology Oncology PC-Westville, Westville, Indiana, United States
Mercy Cancer Center-West Lakes, Clive, Iowa, United States
Mission Cancer and Blood - West Des Moines, Clive, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP, Des Moines, Iowa, United States
Mission Cancer and Blood - Des Moines, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Mission Cancer and Blood - Laurel, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
Mercy Medical Center-Sioux City, Sioux City, Iowa, United States
Saint Luke's Regional Medical Center, Sioux City, Iowa, United States
Methodist West Hospital, West Des Moines, Iowa, United States
Mercy Medical Center-West Lakes, West Des Moines, Iowa, United States
Saint Elizabeth Healthcare Edgewood, Edgewood, Kentucky, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Pikeville Medical Center, Pikeville, Kentucky, United States
Cancer Center of Acadiana, Lafayette, Louisiana, United States
Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
Christiana Care - Union Hospital, Elkton, Maryland, United States
Baystate Medical Center, Springfield, Massachusetts, United States
OSF Saint Francis Hospital and Medical Group, Escanaba, Michigan, United States
Green Bay Oncology - Iron Mountain, Iron Mountain, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
Corewell Health Lakeland Hospitals - Niles Hospital, Niles, 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
University of Mississippi Medical Center, Jackson, Mississippi, United States
Southeast Cancer Center, Cape Girardeau, Missouri, United States
MU Health Care Goldschmidt Cancer Center, Jefferson City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Saint Vincent Healthcare, Billings, Montana, United States
Montana Cancer Consortium NCORP, Billings, Montana, United States
Saint Vincent Frontier Cancer Center, Billings, Montana, United States
Bozeman Health Deaconess Hospital, Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States
Benefis Sletten Cancer Institute, Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Northern Montana Hospital, Havre, Montana, United States
Saint Peter's Community Hospital, Helena, Montana, United States
Glacier Oncology PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Montana Cancer Specialists, Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
Virtua Memorial, Mount Holly, New Jersey, United States
Virtua Voorhees, Voorhees, New Jersey, United States
Southwest Gynecologic Oncology Associates Inc, Albuquerque, New Mexico, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wayne Memorial Hospital, Goldsboro, North Carolina, United States
AdventHealth Hendersonville, Hendersonville, North Carolina, 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
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
Summa Health System - Akron Campus, Akron, Ohio, United States
Mary Rutan Hospital, Bellefontaine, Ohio, United States
Aultman Health Foundation, Canton, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
University of Cincinnati Cancer Center-UC Medical Center, Cincinnati, Ohio, United States
Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, United States
Bethesda North Hospital, Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Mount Carmel East Hospital, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Columbus NCI Community Oncology Research Program, Columbus, Ohio, United States
Grant Medical Center, Columbus, Ohio, United States
The Mark H Zangmeister Center, Columbus, Ohio, United States
Mount Carmel Health Center West, Columbus, Ohio, United States
Doctors Hospital, Columbus, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Marietta Memorial Hospital, Marietta, Ohio, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, United States
Knox Community Hospital, Mount Vernon, Ohio, United States
Licking Memorial Hospital, Newark, Ohio, United States
Southern Ohio Medical Center, Portsmouth, Ohio, United States
Springfield Regional Medical Center, Springfield, Ohio, United States
Saint Ann's Hospital, Westerville, Ohio, United States
Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
Jefferson Abington Hospital, Abington, Pennsylvania, United States
Saint Luke's University Hospital-Bethlehem Campus, Bethlehem, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Geisinger Medical Group, State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
AnMed Health Hospital, Anderson, South Carolina, United States
Saint Francis Hospital, Greenville, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, 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
University of Tennessee - Knoxville, Knoxville, Tennessee, United States
Parkland Memorial Hospital, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
University of Texas Medical Branch, Galveston, Texas, 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
Danville Regional Medical Center, Danville, Virginia, United States
Hematology Oncology Associates of Fredericksburg Inc, Fredericksburg, Virginia, United States
Centra Alan B Pearson Regional Cancer Center, Lynchburg, Virginia, United States
Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay, 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
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States
Bay Area Medical Center, Marinette, Wisconsin, United States
Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center, Milwaukee, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Aurora Medical Center in Summit, Summit, Wisconsin, United States
Aurora West Allis Medical Center, West Allis, Wisconsin, United States
Rocky Mountain Oncology, Casper, Wyoming, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Name: David M Gershenson
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR