flavopiridol in treating patients with recurrent or persistent endometrial cancer

Conditions: Endometrial 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 flavopiridol in treating patients who have recurrent or persistent endometrial cancer.

objectives: * determine the antitumor activity of flavopiridol in patients with recurrent or persistent endometrial carcinoma. * determine the nature and degree of toxicity of this drug in these patients. outline: this is a multicenter study. patients receive flavopiridol iv over 1 hour on days 1-3. treatment repeats every 21 days for at least 2 courses 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: a total of 19-51 patients will be accrued for this study within 10-24 months.

Eligibility criteria:
disease characteristics: * histologically confirmed primary endometrial carcinoma * recurrent or persistent disease * refractory to curative therapy or established treatment * previously treated with only 1 prior cytotoxic chemotherapy regimen (either single agent or combination therapy) for endometrial carcinoma * initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment * at least 1 unidimensionally measurable lesion * at least 20 mm by conventional techniques or * at least 10 mm by spiral ct scan * at least 1 target lesion outside previously irradiated field * ineligible for higher priority gynecologic oncology group (gog) protocol, defined as 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 * pt/ptt normal renal: * creatinine no greater than 1.5 times uln cardiovascular: * no prior thromboembolic events or thrombophlebitis * no prior recent myocardial infarction * no prior angina * no prior cerebrovascular accident * no prior transient ischemic attacks other: * no other invasive malignancy within the past 5 years except nonmelanoma skin cancer * no grade 2 or greater sensory or motor neuropathy * no active infection requiring antibiotics prior concurrent therapy: biologic therapy: * at least 3 weeks since prior biologic or immunologic agents for endometrial carcinoma chemotherapy: * see disease characteristics * at least 3 weeks since prior chemotherapy for endometrial carcinoma and recovered endocrine therapy: * at least 1 week since prior hormonal therapy for endometrial carcinoma * concurrent hormone replacement therapy allowed radiotherapy: * see disease characteristics * at least 3 weeks since prior radiotherapy for endometrial carcinoma and recovered surgery: * at least 3 weeks since prior surgery for endometrial carcinoma and recovered * at least 6 months since prior re-vascularization procedures (e.g., coronary artery bypass graft, carotid endarterectomy or bypass, or angioplasty with or without stents) other: * at least 3 weeks since other prior therapy for endometrial carcinoma * at least 6 months since prior thrombolytic procedures * no prior cyclin-dependent kinase inhibitors * no prior anticancer therapy that would preclude study * no concurrent amifostine or other protective reagents

Keywords: recurrent endometrial carcinoma