Ovarian Cancer Clinical Trial

Topotecan in Treating Patients With Recurrent Ovarian Epithelial 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 topotecan in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.

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Full Description

OBJECTIVES: I. Determine the antitumor activity of topotecan in patients with recurrent platinum sensitive ovarian epithelial or primary peritoneal cancer. II. Determine the nature and degree of toxicity of this treatment regimen in these patients.

OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-3. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent ovarian epithelial or primary peritoneal carcinoma Bidimensionally measurable disease (ascites and pleural effusions not considered measurable) Platinum sensitive (defined as treatment free interval following response to platinum of greater than 6 months) One prior platinum based chemotherapy regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound required

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least lower limit of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and alkaline phosphatase no greater that 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No active infection requiring antibiotics No neuropathy greater than grade 1 Not pregnant Negative pregnancy test Fertile patients must use effective contraception No prior malignancy within past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic or immunologic agents Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy Patients with no prior paclitaxel therapy may receive second regimen that includes paclitaxel No other prior or concurrent cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens No prior topotecan Endocrine therapy: At least one week since prior hormonal therapy for malignant tumor Prior and concurrent hormone replacement therapy allowed Radiotherapy: No prior or concurrent radiotherapy to target sites No prior radiotherapy to greater than 25% of bone marrow Recovered from prior radiotherapy Surgery: Recovered from prior surgery Other: No prior cancer treatment that contraindicates study

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00005029

Recruitment Status:

Terminated

Sponsor:

Gynecologic Oncology Group

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There are 71 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
MBCCOP - Hawaii
Honolulu Hawaii, 96813, United States
MBCCOP - University of Illinois at Chicago
Chicago Illinois, 60612, 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 - Central Illinois
Decatur Illinois, 62526, United States
CCOP - Evanston
Evanston Illinois, 60201, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, 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
Tufts University School of Medicine
Boston Massachusetts, 02111, 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 Air Force Base Mississippi, 39534, United States
Ellis Fischel Cancer Center
Columbia Missouri, 65203, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65807, 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
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
CCOP - Greenville
Greenville South Carolina, 29615, 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
CCOP - Scott and White Hospital
Temple Texas, 76508, 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:

NCT00005029

Recruitment Status:

Terminated

Sponsor:


Gynecologic Oncology Group

How clear is this clinincal trial information?

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