Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney 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 unresectable or metastatic kidney cancer.

Detailed Description
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OBJECTIVES: Determine the confirmed and unconfirmed complete and partial responses in patients with unresectable or metastatic renal cell cancer treated with flavopiridol. Determine the 6-month time to treatment failure rate and overall survival rate of patients treated with this drug. Determine the qualitative and quantitative toxic effects of this drug in this patient population. Determine, in a preliminary manner, the association of tumor response with pretreatment tumor proliferative and apoptotic rates in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.

Official Title
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A Phase II Study of Flavopiridol 1 Hour Bolus Days 1-3 Q 21 Days in Patients With Advanced Renal Cell Cancer

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: alvocidib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable primary (M0) or metastatic renal cell cancer At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Soft tissue disease that has been previously irradiated within the past 2 months is not considered measurable Soft tissue disease within a previously irradiated field is considered measurable provided disease has progressed and other measurable disease exists outside of the radiation field No prior or concurrent brain metastases PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: No hypercoagulable state other than renal cell cancer Hepatic: Not specified Renal: Not specified Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No prior isolated occurrence of deep venous thrombosis within the past 6 months Pulmonary: No prior isolated occurrence of pulmonary embolism within the past 6 months Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission No history of allergic reactions to compounds of similar chemical or biologic composition to flavopiridol (e.g., staurosporine, deschloroflavopiridol, or butyrolactone I) No other uncontrolled illness (e.g., diabetes mellitus) No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: 1 prior immunotherapy regimen comprising interferon and/or interleukin-2 allowed At least 28 days since prior immunotherapy and recovered No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: No prior chemotherapy for renal cell cancer Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 21 days since prior radiotherapy and recovered Surgery: See Disease Characteristics Prior resection of primary tumor allowed At least 28 days since prior surgery and recovered
Sexes Eligible for Study
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All

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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stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer