Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer
A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or CT-2103 Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy
6 other identifiers
interventional
1,157
1 country
315
Brief Summary
This randomized phase III trial studies paclitaxel to see how well it works compared to polyglutamate paclitaxel or observation only in treating patients with stage III or stage IV ovarian epithelial, peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and polyglutamate paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paclitaxel and polyglutamate paclitaxel may also stop the growth of ovarian epithelial or peritoneal cancer by blocking blood flow to the tumor. Sometimes, after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether paclitaxel is more effective than polyglutamate paclitaxel or observation only in treating ovarian epithelial, peritoneal, or fallopian tube cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2005
Longer than P75 for phase_3
315 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
Study Start
First participant enrolled
March 21, 2005
CompletedFirst Submitted
Initial submission to the registry
April 18, 2005
CompletedFirst Posted
Study publicly available on registry
April 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2015
CompletedResults Posted
Study results publicly available
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2022
CompletedSeptember 30, 2021
September 1, 2021
9.9 years
April 18, 2005
February 22, 2021
September 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact.
All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next five years.
Secondary Outcomes (4)
Progression-free Survival
Progression was assessed every 8 weeks for the first 15 months, then every 3 months, up to 14.2 years.
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0
Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.
Patient-Reported Quality of Life (QOL)
1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment
Patient-Reported Peripheral Neuropathy Symptoms
1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment
Study Arms (3)
Arm I (paclitaxel poliglumex)
EXPERIMENTALPatients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Arm II (paclitaxel)
ACTIVE COMPARATORPatients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Arm III (observation)
OTHERPatients receive no further anticancer treatment until evidence of disease progression.
Interventions
Correlative studies
Given IV
Given IV
Ancillary studies
Eligibility Criteria
You may qualify if:
- Patients with a histologic diagnosis of primary peritoneal carcinoma, or stage III or IV epithelial ovarian or fallopian tube carcinoma, with either optimal (=\< 1 cm residual disease) or suboptimal residual disease following initial surgery; all patients must have had appropriate surgery for ovarian, primary peritoneal or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage
- Patients with the following histologic epithelial cell types are eligible:
- Serous adenocarcinoma
- Endometrioid adenocarcinoma
- Mucinous adenocarcinoma
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Mixed epithelial carcinoma
- Transitional cell carcinoma
- Malignant Brenner tumor
- Adenocarcinoma not otherwise specified (NOS)
- Patients must have completed treatment within the past 12 weeks with at least 5 cycles and not more than 8 cycles of a platinum (IV or intraperitoneal \[IP\]) and paclitaxel or docetaxel-based combination chemotherapy and have no symptoms suggestive of persistent cancer, normal (no evidence of cancer) computed tomography (CT) scan of the abdomen/pelvis and normal cancer antigen 125 (CA-125) following this therapy
- Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive diagnosis of stage III or IV epithelial ovarian, primary peritoneal or, fallopian tube (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided that they have undergone interval abdominal surgery after at least one but no more than six cycles of standard chemotherapy; such surgery must meet the same criteria as for those undergoing up front surgery, including tissue diagnosis for confirmation of primary tumor site and stage III or IV disease; also, patients must have received at least two cycles after interval abdominal surgery
- Absolute neutrophil count \>= 1,500/ul, equivalent to Common Toxicity Criteria (CTCAE version \[v\]3.0) grade 1
- Platelet count \>= 100,000/ul
- +8 more criteria
You may not qualify if:
- Patients with a current diagnosis of epithelial ovarian or fallopian tube tumor of low malignant potential (LMP) (Borderline carcinomas) are not eligible; patients with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for their ovarian LMP tumor
- Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from other sites to the ovary and low malignant potential tumors including so called micropapillary serous carcinomas are not eligible
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease
- Patients who have received investigational therapies, and/or biological therapies (i.e. Bevacizumab or Erlotinib) for their epithelial ovarian, primary peritoneal or fallopian tube cancers or for any other abdominal or pelvic tumor, are not excluded; however, biologics cannot be continued concurrent with the GOG-012 maintenance treatment (or observation); patients who have received prior chemotherapy for any other abdominal or pelvic tumor (except as noted above) are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 3 years prior to registration, and that the patient remains free of recurrent or metastatic disease
- Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met:
- Stage not greater than I-B
- Less than 3 mm invasion without vascular or lymphatic invasion
- No poorly differentiated subtypes, including papillary serous, clear cell, or other Federation of Gynecology and Obstetrics (FIGO) Grade 3 lesions
- With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded
- Patients with acute hepatitis, or known chronic hepatitis
- Patients with an active infection that requires antibiotics
- Patients with ongoing gastrointestinal bleeding requiring blood product support
- Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow up
- Patients with unstable angina or those who have had a myocardial infarction within the past six months; patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months
- Patients are excluded who have had prior therapy with CT-2103
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GOG Foundationlead
- National Cancer Institute (NCI)collaborator
Study Sites (315)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Tennessee Valley Gynecologic Oncology
Huntsville, Alabama, 35805, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Highlands Oncology Group PA - Fayetteville
Fayetteville, Arkansas, 72703, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Long Beach Memorial Medical Center-Todd Cancer Institute
Long Beach, California, 90806, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, 94040, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of California San Diego
San Diego, California, 92103, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Western States Cancer Research NCORP
Denver, Colorado, 80222, United States
Rocky Mountain Gynecologic Oncology PC
Englewood, Colorado, 80110, 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
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Littleton Adventist Hospital
Littleton, Colorado, 80122, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Parker Adventist Hospital
Parker, Colorado, 80138, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
University of Connecticut
Farmington, Connecticut, 06030, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Yale University
New Haven, Connecticut, 06520, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Florida Gynecologic Oncology
Fort Myers, Florida, 33905, United States
Southeast Gynecologic Oncology Associates
Jacksonville, Florida, 32204, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Women's Cancer Associates
St. Petersburg, Florida, 33713, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501, United States
Central Georgia Gynecologic Oncology
Macon, Georgia, 31201, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale, Illinois, 60521, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, 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
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
Saint Vincent Hospital and Health Care Center
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
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
The Community Hospital
Munster, Indiana, 46321, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC-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
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Saint Luke's South Hospital
Overland Park, Kansas, 66213, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, 66208, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, 40202, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
Woman's Hospital
Baton Rouge, Louisiana, 70817, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103, United States
CHRISTUS Highland Medical Center
Shreveport, Louisiana, 71105, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Christiana Care - Union Hospital
Elkton, Maryland, 21921, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
UMass Memorial Medical Center - Memorial Division
Worcester, Massachusetts, 01605, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Ascension Saint John Hospital
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
Lakeland Hospital Niles
Niles, Michigan, 49120, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Saint Dominic-Jackson Memorial Hospital
Jackson, Mississippi, 39216, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Singing River Hospital
Pascagoula, Mississippi, 39581, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Mercy Hospital Joplin
Joplin, Missouri, 64804, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63104, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Center of Hope at Renown Medical Center
Reno, Nevada, 89502, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07753, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, 87106, United States
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, 88011, United States
Women's Cancer Care Associates LLC
Albany, New York, 12208, United States
Island Gynecologic Oncology
Brightwaters, New York, 11718, United States
State University of New York Downstate Medical Center
Brooklyn, New York, 11203, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
New York Hospital Medical Center of Queens
Fresh Meadows, New York, 11365, United States
Queens Hospital Center
Jamaica, New York, 11432, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
NYU Winthrop Hospital
Mineola, New York, 11501, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Mount Sinai Hospital
New York, New York, 10029, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, 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
Westchester Medical Center
Valhalla, New York, 10595, United States
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, 28816, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Gynecologic Oncology Network
Greenville, North Carolina, 27834, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina, 28401, 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
Summa Health System - Akron Campus
Akron, Ohio, 44304, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, 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
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Kettering Medical Center
Kettering, Ohio, 45429, 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
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Compass Oncology Rose Quarter
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, 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
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Reading Hospital
West Reading, Pennsylvania, 19611, 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
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Black Hills Obstetrics and Gynecology
Rapid City, South Dakota, 57701, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Chattanooga Gynecological Oncology
Chattanooga, Tennessee, 37403, United States
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, 37403, United States
Knoxville Gynecologic Cancer Specialists PC
Knoxville, Tennessee, 37920, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106, United States
Dell Seton Medical Center at The University of Texas
Austin, Texas, 78701, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Northern Virginia Pelvic Surgery Associates
Annandale, Virginia, 22003, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Bon Secours Mary Immaculate Hospital
Newport News, Virginia, 23602, United States
Virginia Oncology Associates - Lake Wright
Norfolk, Virginia, 23502, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310, United States
Skagit Valley Hospital Regional Cancer Care Center
Mount Vernon, Washington, 98274, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Pacific Gynecology Specialists
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307, United States
University of Washington Medical Center - Northwest
Seattle, Washington, 98133, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, 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
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, 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
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Vince Lombardi Cancer Clinic - Slinger
Slinger, Wisconsin, 53086, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Related Publications (1)
Copeland LJ, Brady MF, Burger RA, Rodgers WH, Huang HQ, Cella D, O'Malley DM, Street DG, Tewari KS, Bender DP, Morris RT, Lowery WJ, Miller DS, Dewdney SB, Spirtos NM, Lele SB, Guntupalli S, Ueland FR, Glaser GE, Mannel RS, DiSaia PJ. Phase III Randomized Trial of Maintenance Taxanes Versus Surveillance in Women With Advanced Ovarian/Tubal/Peritoneal Cancer: A Gynecologic Oncology Group 0212:NRG Oncology Study. J Clin Oncol. 2022 Dec 10;40(35):4119-4128. doi: 10.1200/JCO.22.00146. Epub 2022 Jun 27.
PMID: 35759733DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher Purdy on behalf of Austin Miller PhD
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Larry J Copeland
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
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2005
First Posted
April 19, 2005
Study Start
March 21, 2005
Primary Completion
February 3, 2015
Study Completion
February 22, 2022
Last Updated
September 30, 2021
Results First Posted
April 1, 2021
Record last verified: 2021-09