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Paclitaxel or Polyglutamate Paclitaxel or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Peritoneal Cancer or Fallopian Tube Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00108745
First received: April 18, 2005
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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 or 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.


Condition Intervention Phase
Brenner Tumor
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Epithelial Cancer
Stage IIIA Primary Peritoneal Cavity Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Epithelial Cancer
Stage IIIB Primary Peritoneal Cavity Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Epithelial Cancer
Stage IIIC Primary Peritoneal Cavity Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Epithelial Cancer
Stage IV Primary Peritoneal Cavity Cancer
Drug: paclitaxel poliglumex
Other: clinical observation
Drug: paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From protocol entry to death due to any cause, or for living patients, date of last contact, up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: From protocol entry to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause, up to 5 years ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects assessed by Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Quality of life assessed by Functional Assessment of Cancer Therapy-Ovarian-Trial Outcome Index (FACT-O-TOI) and Functional Assessment of Cancer Therapy-Gynecologic Oncology Group/Neurotoxicity version 4 (FACT-GOG/NTX4) [ Time Frame: Up to 24 months after study enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: March 2005
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (paclitaxel poliglumex)
Patients 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.
Drug: paclitaxel poliglumex
Given IV
Other Names:
  • CT-2103
  • paclitaxel-polyglutamate polymer
  • PG-TXL
  • polyglutamate paclitaxel
  • Xyotax
Active Comparator: Arm II (paclitaxel)
Patients 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.
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Arm III (observation)
Patients receive no further anticancer treatment until evidence of disease progression.
Other: clinical observation
Undergo observation
Other Name: observation

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine whether CT-2103 (polyglutamate paclitaxel) or paclitaxel, administered to women with advanced ovarian, primary peritoneal or fallopian tube cancer who have attained a clinically-defined complete response to primary platinum/taxane-based chemotherapy ("consolidation/maintenance therapy") will reduce the death rate, compared to re-treatment at the time of documented disease progression.

II. To determine if, in this clinical setting, CT-2103 produces a more favorable toxicity profile (with a particular focus on peripheral neuropathy as measured by the Gynecologic Oncology Group [GOG] NTX4) and superior quality-of-life (as measured by the Functional Assessment of Cancer Therapy-Ovarian [FACT-O]), compared to paclitaxel.

SECONDARY OBJECTIVES:

I. To explore the relationship between expression of several of the angiogenic markers and overall survival or progression-free survival in patients randomized to CT-2103, paclitaxel, or no treatment.

II. To assess the association among the various tissue and serum markers of angiogenesis, and compare the ability of different combinations of these markers to predict patient outcome including overall survival and progression-free survival in patients randomized to CT-2103, paclitaxel, or no treatment.

III. To bank deoxyribonucleic acid (DNA) from whole blood for research and evaluate the association between single nucleotide polymorphisms (SNPs) and measures of clinical outcome including overall survival, progression-free survival and adverse events.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage at diagnosis (stage III vs stage IV); presence of macroscopic disease after initial debulking surgery (yes vs no); type of prior taxane-based therapy (docetaxel vs paclitaxel); and route of prior platinum therapy (intraperitoneal vs IV). Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive polyglutamate paclitaxel intravenously (IV) over 10-20 minutes on day 1.

ARM II: Patients receive paclitaxel IV over 3 hours on day 1.

ARM III: Patients receive no further anticancer treatment until evidence of disease progression.

In arms I and II, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 3, 5, and 7 of study treatment, at completion of study treatment, and then at 1 year after completion of study treatment.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 10 years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • The following histologic epithelial cell types are allowed:

    • Serous adenocarcinoma
    • Endometrioid adenocarcinoma
    • Mucinous adenocarcinoma
    • Undifferentiated carcinoma
    • Clear cell adenocarcinoma
    • Mixed epithelial carcinoma
    • Transitional cell carcinoma
    • Malignant Brenner tumor
    • Adenocarcinoma not otherwise specified
  • Patients must have completed treatment within the past 12 weeks with at least 5 courses and not more than 8 courses 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 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
  • Platelet count >= 100,000/ul
  • Creatinine =< 1.5 times institutional upper limit of normal (IULN)
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase =< 2.5 times ULN
  • Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 1
  • GOG performance status of 0, 1, or 2
  • Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
  • Patients must complete pre-entry assessments

Exclusion Criteria:

  • 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
  • Patients with active bleeding or an unexplained prothrombin time (PT) or partial thromboplastin time (PTT) > institutional upper limit normal (ULN)
  • Patients who are pregnant or nursing are excluded; patients who may become pregnant must practice an effective method of birth control
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108745

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Tennessee Valley Gynecologic Oncology
Huntsville, Alabama, United States, 35805
United States, Arizona
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Arkansas
Highlands Oncology Group PA - Fayetteville
Fayetteville, Arkansas, United States, 72703
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Long Beach Memorial Medical Center-Todd Cancer Institute
Long Beach, California, United States, 90806
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Kaiser Permanente Medical Care Program - Los Angeles Medical Center &amp; Sunset Hospital
Los Angeles, California, United States, 90027
University of California at Los Angeles (UCLA )
Los Angeles, California, United States, 90095
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States, 94040
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868
Sutter General Hospital
Sacramento, California, United States, 95816
University of California at Davis Cancer Center
Sacramento, California, United States, 95817
University of California San Diego
San Diego, California, United States, 92103
UCSF-Mount Zion
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Rose Medical Center
Denver, Colorado, United States, 80220
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Rocky Mountain Gynecologic Oncology PC
Englewood, Colorado, United States, 80110
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
University of Connecticut
Farmington, Connecticut, United States, 06030
Hartford Hospital
Hartford, Connecticut, United States, 06102
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
Yale University
New Haven, Connecticut, United States, 06520
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Florida Gynecologic Oncology
Fort Myers, Florida, United States, 33905
Southeast Gynecologic Oncology Associates
Jacksonville, Florida, United States, 32204
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Florida Hospital
Orlando, Florida, United States, 32803
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
Women's Cancer Associates
Saint Petersburg, Florida, United States, 33701
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
John B Amos Cancer Center
Columbus, Georgia, United States, 31904
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Central Georgia Gynecologic Oncology
Macon, Georgia, United States, 31201
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Illinois
Chicago, Illinois, United States, 60612
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
Advocate Lutheran General Hospital.
Park Ridge, Illinois, United States, 60068
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Cancer Center
Urbana, Illinois, United States, 61801
Cadence Cancer Center in Warrenville
Warrenville, Illinois, United States, 60555
United States, Indiana
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States, 46514
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Gynecologic Oncology of Indiana
Indianapolis, Indiana, United States, 46237
Saint Vincent Oncology Center
Indianapolis, Indiana, United States, 46260
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
IU Health La Porte Hospital
La Porte, Indiana, United States, 46350
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
The Community Hospital
Munster, Indiana, United States, 46321
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States, 46563
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46628
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
South Bend Clinic
South Bend, Indiana, United States, 46617
Michiana Hematology Oncology-PC Westville
Westville, Indiana, United States, 46391
United States, Iowa
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita CCOP
Wichita, Kansas, United States, 67214
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
University of Kentucky
Lexington, Kentucky, United States, 40536
Norton Health Care Pavilion - Downtown
Louisville, Kentucky, United States, 40202
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Woman's Hospital
Baton Rouge, Louisiana, United States, 70817
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Christus Schumpert Saint Mary's Place
Shreveport, Louisiana, United States, 71101
United States, Maryland
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, United States, 01605
United States, Michigan
University of Michigan University Hospital
Ann Arbor, Michigan, United States, 48109
University of Michigan
Ann Arbor, Michigan, United States, 48109
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States, 49307
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48502
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Gynecologic Oncology of West Michigan PLLC
Grand Rapids, Michigan, United States, 49546
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Allegiance Health
Jackson, Michigan, United States, 49201
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Michiana Hematology Oncology PC-Niles
Niles, Michigan, United States, 49120
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Lakeland Hospital
St. Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Saint Luke's Hospital of Duluth
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States, 55455
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
Saint Dominic-Jackson Memorial Hospital
Jackson, Mississippi, United States, 39216
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
University of Missouri - Ellis Fischel
Columbia, Missouri, United States, 65212
Freeman Health System
Joplin, Missouri, United States, 64804
Mercy Hospital-Joplin
Joplin, Missouri, United States, 64804
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
Center of Hope at Renown Medical Center
Reno, Nevada, United States, 89502
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States, 08060
Jersey Shore Medical Center
Neptune, New Jersey, United States, 07753
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, United States, 87106
University of New Mexico
Albuquerque, New Mexico, United States, 87106
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, United States, 88011
United States, New York
Women's Cancer Care Associates LLC
Albany, New York, United States, 12208
Island Gynecologic Oncology
Brightwaters, New York, United States, 11718
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
New York Hospital Medical Center of Queens
Fresh Meadows, New York, United States, 11365
Queens Hospital Center
Jamaica, New York, United States, 11432
North Shore University Hospital
Manhasset, New York, United States, 11030
Winthrop University Hospital
Mineola, New York, United States, 11501
North Shore-LIJ Health System/Center for Advanced Medicine
New Hyde Park, New York, United States, 11040
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Mount Sinai Medical Center
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
New York University Langone Medical Center
New York, New York, United States, 10016
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Westchester County Medical Center
Valhalla, New York, United States, 10595
United States, North Carolina
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, United States, 28816
Cone Health Alamance Regional Medical Center
Burlington, North Carolina, United States, 27216
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
Cone Health Cancer Center
Greensboro, North Carolina, United States, 27403
Gynecologic Oncology Network
Greenville, North Carolina, United States, 27834
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Aultman Health Foundation
Canton, Ohio, United States, 44710
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Kettering Medical Center
Kettering, Ohio, United States, 45429
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Compass Oncology Rose Quarter
Portland, Oregon, United States, 97227
Providence Cancer Center -The Plaza
Portland, Oregon, United States, 97213
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States, 18015
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Upstate Carolina CCOP
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Black Hills Obstetrics and Gynecology
Rapid City, South Dakota, United States, 57701
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, United States, 37403
Chattanooga Gynecological Oncology
Chattanooga, Tennessee, United States, 37403
Knoxville Gynecologic Cancer Specialists PC
Knoxville, Tennessee, United States, 37920
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States, 38120
United States, Texas
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, United States, 79106
University Medical Center Brackenridge
Austin, Texas, United States, 78701
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555-0565
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77026-1967
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Vermont
Fletcher Allen Health Care-Medical Center
Burlington, Vermont, United States, 05401
United States, Virginia
Northern Virginia Pelvic Surgery Associates
Annandale, Virginia, United States, 22003
University of Virginia
Charlottesville, Virginia, United States, 22908
Bon Secours Mary Immaculate Hospital
Newport News, Virginia, United States, 23602
Virginia Oncology Associates - Lake Wright
Norfolk, Virginia, United States, 23502
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, United States, 24016
United States, Washington
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States, 98310
Skagit Valley Hospital Regional Cancer Care Center
Mount Vernon, Washington, United States, 98273
University of Washington Medical Center
Seattle, Washington, United States, 98195
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Northwest Hospital
Seattle, Washington, United States, 98133
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Virginia Mason CCOP
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Tacoma General Hospital
Tacoma, Washington, United States, 98405
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
United States, Wisconsin
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States, 53024
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States, 53081
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, United States, 53188
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Larry Copeland Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00108745     History of Changes
Other Study ID Numbers: GOG-0212, NCI-2009-00586, CDR0000422427, GOG-0212, GOG-0212, GOG-0212, U10CA027469
Study First Received: April 18, 2005
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Cystadenocarcinoma
Cystadenocarcinoma, Serous
Cystadenocarcinoma, Mucinous
Carcinoma
Carcinoma, Endometrioid
Brenner Tumor
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms, Cystic, Mucinous, and Serous
Endometrial Neoplasms
Uterine Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014