paclitaxel in treating patients with ovarian epithelial cancer or primary peritoneal cancer

Conditions: Ovarian Cancer; Primary Peritoneal Cavity 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 paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.

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.

Eligibility 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

Keywords: recurrent ovarian epithelial cancer primary peritoneal cavity cancer