Ovarian Cancer, Primary Peritoneal Cavity Cancer
Conditions
Keywords
recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
Brief 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 paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
Detailed description
OBJECTIVES: * Determine the antitumor activity of paclitaxel in patients with recurrent or persistent platinum- and paclitaxel-resistant ovarian epithelial or primary peritoneal cancer. * Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: Patients receive paclitaxel IV over 1 hour once weekly for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 6-12 months.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent or persistent ovarian epithelial or primary peritoneal cancer * Measurable disease * At least 1 lesion measured in at least 1 dimension * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * At least 1 target lesion * Tumors within a previously irradiated field considered non-target lesions * Paclitaxel resistant * Treatment-free interval of less than 6 months duration after treatment with prior paclitaxel OR * Progression during prior paclitaxel-based therapy * Platinum resistant or refractory * Treatment-free interval of less than 6 months duration after treatment with prior platinum OR * Progression during prior platinum-based therapy * Ineligible for higher priority GOG protocol (any active GOG phase III protocol for the same patient population) PATIENT CHARACTERISTICS: Age: * Any age Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring antibiotics * No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer * No grade 2 or greater neuropathy (sensory and motor) PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic or immunologic agents for cancer Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy for cancer and recovered * Received at least 1 but no more than 2 prior platinum-based chemotherapy regimens containing carboplatin, cisplatin, or other organoplatinum compound for primary or recurrent disease * Initial treatment may include high-dose therapy, consolidation, or extended therapy * Received at least 1 prior paclitaxel-based chemotherapy regimen * No prior paclitaxel or docetaxel with a schedule of less than a 3-week interval between doses * No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens Endocrine therapy: * At least 1 week since prior hormonal therapy for cancer * Concurrent hormone replacement therapy allowed Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy for cancer and recovered * No prior radiotherapy to site(s) of measurable disease * No prior radiotherapy to more than 25% of marrow-bearing areas Surgery: * At least 3 weeks since prior surgery for cancer and recovered Other: * At least 3 weeks since other prior therapy for cancer * No prior anticancer treatment that would preclude study * No concurrent amifostine or other protective reagents
Countries
United States