Ovarian Cancer Clinical Trial

Docetaxel in Treating Patients With Recurrent or Refractory Ovarian or Primary Peritoneal Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory ovarian or primary peritoneal cancer.

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Full Description

OBJECTIVES: I. Estimate the antitumor activity of docetaxel in patients with paclitaxel- and platinum-resistant, recurrent or refractory, ovarian epithelial or primary peritoneal cancer who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of docetaxel in this patient population.

OUTLINE: Patients receive docetaxel as a 1 hour continuous intravenous infusion. Courses are repeated every 21 days. Treatment continues in the absence of unacceptable toxic effects or disease progression. All patients are followed every 3 months for 2 years, every 6 months for 3 years, and then until death.

PROJECTED ACCRUAL: A total of 23-56 patients will be accrued for this study.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory ovarian epithelial or peritoneal cancer Platinum resistant AND paclitaxel resistant Progressed on or within 6 months of completing therapy with paclitaxel and platinum either alone or in combination Bidimensionally measurable disease (excludes ascites and pleural effusions) Brain metastases allowed provided that other measurable disease exists and brain lesions required no therapy for 6 months and are not life threatening Not eligible for higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 1.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No significant infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E) No other invasive malignancies within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Must have had at least 1 prior platinum based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound Must have had at least 1 prior paclitaxel based chemotherapeutic regimen 1 or 2 prior chemotherapy regimens containing platinum and paclitaxel allowed Recovered from toxic effects No prior docetaxel Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Recovered from effects of recent surgery Other: At least 3 weeks since any prior therapy directed at the malignant tumor No prior cancer treatment that contraindicates this protocol therapy

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00004037

Recruitment Status:

Terminated

Sponsor:

Gynecologic Oncology Group

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There are 65 Locations for this study

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University of Alabama Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
CCOP - Greater Phoenix
Phoenix Arizona, 85006, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
Women's Cancer Center
Palo Alto California, 94304, United States
University of Colorado Cancer Center
Denver Colorado, 80262, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington District of Columbia, 20007, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Emory University Hospital - Atlanta
Atlanta Georgia, 30322, United States
CCOP - Atlanta Regional
Atlanta Georgia, 30342, United States
MBCCOP - Hawaii
Honolulu Hawaii, 96813, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
CCOP - Evanston
Evanston Illinois, 60201, United States
CCOP - Central Illinois
Springfield Illinois, 62526, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington Kentucky, 40536, United States
Johns Hopkins Oncology Center
Baltimore Maryland, 21287, United States
Medicine Branch
Bethesda Maryland, 20892, United States
Radiation Oncology Branch
Bethesda Maryland, 20892, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01655, United States
CCOP - Ann Arbor Regional
Ann Arbor Michigan, 48106, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Keesler Medical Center - Keesler AFB
Keesler AFB Mississippi, 39534, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68131, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Cooper Hospital/University Medical Center
Camden New Jersey, 08103, United States
Cancer Center of Albany Medical Center
Albany New York, 12208, United States
State University of New York Health Science Center at Brooklyn
Brooklyn New York, 11203, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
University of Rochester Cancer Center
Rochester New York, 14642, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook New York, 11790, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Brookview Research, Inc.
Winston-Salem North Carolina, 27103, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Barrett Cancer Center, The University Hospital
Cincinnati Ohio, 45219, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Cleveland Clinic Cancer Center
Cleveland Ohio, 44195, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus Ohio, 43210, United States
University of Oklahoma College of Medicine
Oklahoma City Oklahoma, 73190, United States
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
Tulsa Oklahoma, 74136, United States
CCOP - Columbia River Program
Portland Oregon, 97213, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Pennsylvania Hospital
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
CCOP - Baptist Cancer Institute
Memphis Tennessee, 38117, United States
Simmons Cancer Center - Dallas
Dallas Texas, 75235, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Cancer Center, University of Virginia HSC
Charlottesville Virginia, 22908, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
Tacoma General Hospital
Tacoma Washington, 98405, United States
NCIC-Clinical Trials Group
Kingston Ontario, K7L 3, Canada

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00004037

Recruitment Status:

Terminated

Sponsor:


Gynecologic Oncology Group

How clear is this clinincal trial information?

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