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
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)
5 other identifiers
interventional
50
1 country
248
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2010
Longer than P75 for phase_3
248 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2010
CompletedFirst Posted
Study publicly available on registry
March 5, 2010
CompletedStudy Start
First participant enrolled
October 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2015
CompletedResults Posted
Study results publicly available
March 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2027
ExpectedApril 30, 2026
February 1, 2026
4.4 years
March 4, 2010
July 18, 2018
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Every cycle while on treatment, up to 5 years
Progression-free Survival
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.
Objective Tumor Response
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
Patient Reported 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
Patient Reported Quality of Life
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
Other Outcomes (1)
Numbers and Percentages of Patients With Mutations in the Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Oncogene
Baseline
Study Arms (4)
Arm I (carboplatin and paclitaxel)
EXPERIMENTALPatients receive carboplatin 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 (oxaliplatin and capecitabine)
EXPERIMENTALPatients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm III (carboplatin, paclitaxel, bevacizumab)
EXPERIMENTALPatients 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 (oxaliplatin, capecitabine, bevacizumab)
EXPERIMENTALPatients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
Interventions
Given IV
Given PO
Given IV
Correlative studies
Given IV
Given IV
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
- +7 more criteria
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- NRG Oncologycollaborator
Study Sites (248)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36688, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
East Bay Radiation Oncology Center
Castro Valley, California, 94546, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546, United States
Bay Area Breast Surgeons Inc
Emeryville, California, 94608, United States
Epic Care Partners in Cancer Care
Emeryville, California, 94608, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
El Camino Hospital
Mountain View, California, 94040, United States
Wilma Chan Highland Hospital
Oakland, California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
Hematology and Oncology Associates-Oakland
Oakland, California, 94609, United States
Tom K Lee Inc
Oakland, California, 94609, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, 94806, United States
Olive View-University of California Los Angeles Medical Center
Sylmar, California, 91342, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
Boulder Community Foothills Hospital
Boulder, Colorado, 80303, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
AdventHealth Porter
Denver, Colorado, 80210, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Western States Cancer Research NCORP
Denver, Colorado, 80222, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501, United States
Banner North Colorado Medical Center
Greeley, Colorado, 80631, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
AdventHealth Littleton
Littleton, Colorado, 80122, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, 80539, United States
AdventHealth Parker
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, 80401, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, 06904, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
OSF Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Graham Hospital Association
Canton, Illinois, 61520, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Havana
Havana, Illinois, 62644, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale, Illinois, 60521, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Holy Family Medical Center
Monmouth, Illinois, 61462, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, 61462, United States
Carle BroMenn Medical Center
Normal, Illinois, 61761, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Swedish American Hospital
Rockford, Illinois, 61104, United States
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, 61362, United States
Elkhart Clinic
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Cancer Care Partners LLC
Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, 46391, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51102, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, 41017, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Pikeville Medical Center
Pikeville, Kentucky, 41501, United States
Cancer Center of Acadiana
Lafayette, Louisiana, 70503, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Christiana Care - Union Hospital
Elkton, Maryland, 21921, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Beacon Kalamazoo
Kalamazoo, Michigan, 49048, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703, United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Montana Cancer Consortium NCORP
Billings, Montana, 59102, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology
Kalispell, Montana, 59901, United States
Logan Health Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, 87106, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
AdventHealth Hendersonville
Hendersonville, North Carolina, 28792, United States
Southeast Clinical Oncology Research Consortium NCORP
Winston-Salem, North Carolina, 27104, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Mid Dakota Clinic
Bismarck, North Dakota, 58501, United States
Saint Alexius Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Summa Health System - Akron Campus
Akron, Ohio, 44304, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Mount Carmel East Hospital
Columbus, Ohio, 43213, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, 43215, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662, United States
Springfield Regional Medical Center
Springfield, Ohio, 45504, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Jefferson Abington Hospital
Abington, Pennsylvania, 19001, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
AnMed Health Hospital
Anderson, South Carolina, 29621, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, 22408, United States
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia, 24501, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Related Publications (1)
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PMID: 37185961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The majority of patients were deemed not to have primary mucinous ovarian cancer post hoc. The trial accrued slowly and was stopped early.
Results Point of Contact
- Title
- Linda Gedeon on behalf of William Brady, PhD
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
David M Gershenson
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2010
First Posted
March 5, 2010
Study Start
October 12, 2010
Primary Completion
February 25, 2015
Study Completion (Estimated)
March 12, 2027
Last Updated
April 30, 2026
Results First Posted
March 18, 2019
Record last verified: 2026-02