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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: David M Gershenson

Affiliation: NRG Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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