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.
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.
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
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There are 71 Locations for this study
Birmingham Alabama, 35294, United States
Phoenix Arizona, 85006, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Palo Alto California, 94304, United States
Denver Colorado, 80262, United States
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20307, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Honolulu Hawaii, 96813, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Evanston Illinois, 60201, United States
Indianapolis Indiana, 46202, United States
Des Moines Iowa, 50309, United States
Iowa City Iowa, 52242, United States
Lexington Kentucky, 40536, United States
Baltimore Maryland, 21287, United States
Bethesda Maryland, 20892, United States
Bethesda Maryland, 20892, United States
Boston Massachusetts, 02111, United States
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48106, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55455, United States
Jackson Mississippi, 39216, United States
Keesler Air Force Base Mississippi, 39534, United States
Columbia Missouri, 65203, United States
Kansas City Missouri, 64131, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Omaha Nebraska, 68131, United States
Las Vegas Nevada, 89106, United States
Camden New Jersey, 08103, United States
Albany New York, 12208, United States
Brooklyn New York, 11203, United States
Manhasset New York, 11030, United States
New York New York, 10021, United States
Rochester New York, 14642, United States
Stony Brook New York, 11790, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27103, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Oklahoma City Oklahoma, 73190, United States
Tulsa Oklahoma, 74136, United States
Portland Oregon, 97213, United States
Abington Pennsylvania, 19001, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Wynnewood Pennsylvania, 19096, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Memphis Tennessee, 38117, United States
Dallas Texas, 75235, United States
Houston Texas, 77030, United States
Temple Texas, 76508, United States
Charlottesville Virginia, 22908, United States
Seattle Washington, 98195, United States
Tacoma Washington, 98405, United States
Kingston Ontario, K7L 3, Canada
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