docetaxel in treating patients with recurrent or persistent endometrial carcinoma (cancer)

Conditions: Endometrial Cancer

Summary: rationale: drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. purpose: this phase ii trial is studying how well docetaxel works in treating patients with recurrent or persistent endometrial carcinoma (cancer).

objectives: * determine the antitumor activity of docetaxel in patients with recurrent or persistent endometrial carcinoma. * determine the toxicity of this drug in these patients. outline: this is a multicenter study. patients receive docetaxel iv over 1 hour on days 1, 8, and 15. courses repeat every 28 days 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 19-51 patients will be accrued for this study within 10-18 months.

Eligibility criteria:
disease characteristics: * histologically confirmed endometrial carcinoma * recurrent or persistent disease * refractory to curative or standard therapy * measurable disease * at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral ct scan * at least 1 target lesion * tumors within a previously irradiated field are not considered target lesions * received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment * one additional non-cytotoxic regimen for recurrent or persistent disease allowed, including monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction * ineligible for a higher priority gog protocol patient characteristics: age * any age performance status * gog 0-2 life expectancy * not specified hematopoietic * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 hepatic * sgot ≤ 2.5 times upper limit of normal (uln) * alkaline phosphatase ≤ 2.5 times uln * bilirubin ≤ 1.5 times uln renal * creatinine ≤ 1.5 times uln other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no neuropathy (sensory and motor) ≥ grade 2 * no active infection requiring antibiotics * no other invasive malignancy within the past 5 years except nonmelanoma skin cancer prior concurrent therapy: biologic therapy * see disease characteristics * at least 3 weeks since prior biologic or immunologic therapy for malignant tumor * no concurrent prophylactic growth factors * no concurrent prophylactic thrombopoietic agents chemotherapy * see disease characteristics * recovered from prior chemotherapy * no more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic drugs) endocrine therapy * at least 1 week since prior hormonal therapy for malignant tumor * concurrent hormone replacement therapy allowed radiotherapy * see disease characteristics * recovered from prior radiotherapy surgery * recovered from prior surgery other * at least 3 weeks since other prior therapy for malignant tumor * no prior anticancer therapy that would preclude current protocol therapy * no concurrent amifostine or other protective reagents

Keywords: recurrent endometrial carcinoma stage iii endometrial carcinoma stage iv endometrial carcinoma