Ovarian Cancer Clinical Trial
Combination Chemotherapy in Treating Patients With Previously Untreated Stage III or Stage IV 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients with previously untreated stage III or stage IV ovarian or primary peritoneal cancer.
Full Description
OBJECTIVES: I. Determine the feasibility of administering multiple courses of chemotherapy without excessive dose modification or treatment delay in patients with previously untreated ovarian epithelial carcinoma or primary peritoneal carcinoma. II. Determine the response rate (in patients with measurable disease) and progression-free interval in these patients receiving this treatment.
OUTLINE: This is a feasibility study. On day 1, patients receive paclitaxel as a 3 hour continuous IV infusion followed by carboplatin as a 30 minute infusion. Gemcitabine is administered by continuous infusion over 30 minutes on day 1 following carboplatin and on day 8. In the absence of disease progression or unacceptable toxicity, courses repeat every 21 days for a maximum of 8 courses. Patients are followed every 3 months for 2 years, every 6 months for the next 3 years, and annually thereafter.
PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study within approximately 2 years.
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed, previously untreated: Stage III or stage IV ovarian epithelial cancer Stage III or stage IV primary peritoneal cancer
PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 mg/dL Other: Effective contraception required of fertile patients No significant infections No other severe medical problems that would subject patient to undue risk from this protocol No other active malignancy within past 5 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for this or any other malignancy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for this or any other malignancy Surgery: No prior surgery other than cytoreductive surgery and recovered
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There are 62 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
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
Atlanta Georgia, 30342, United States
Honolulu Hawaii, 96813, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Evanston Illinois, 60201, United States
Springfield Illinois, 62526, United States
Indianapolis Indiana, 46202, 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
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48106, United States
Detroit Michigan, 48201, United States
Jackson Mississippi, 39216, United States
Keesler AFB Mississippi, 39534, United States
Kansas City Missouri, 64131, United States
Saint Louis Missouri, 63110, 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
Charleston South Carolina, 29425, United States
Spartanburg South Carolina, 29303, United States
Memphis Tennessee, 38117, United States
Dallas Texas, 75235, United States
Houston Texas, 77030, United States
Seattle Washington, 98195, United States
Tacoma Washington, 98405, United States
Kingston Ontario, K7L 3, Canada
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