Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Evaluation of Flavopiridol (NSC# 649890) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Drug: alvocidib


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: alvocidib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent endometrial carcinoma