Endometrial Cancer
Conditions
Keywords
recurrent endometrial carcinoma
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 flavopiridol in treating patients who have recurrent or persistent endometrial cancer.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Countries
Australia, Canada, Norway, United Kingdom, United States