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.
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.
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
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There are 65 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
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
Minneapolis Minnesota, 55455, 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
Charlottesville Virginia, 22908, United States
Seattle Washington, 98195, United States
Tacoma Washington, 98405, United States
Kingston Ontario, K7L 3, Canada
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