Kidney Cancer Clinical Trial
Official title:
A Phase II Study of Flavopiridol 1 Hour Bolus Days 1-3 Q 21 Days in Patients With Advanced Renal Cell Cancer
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.
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.
;
Primary Purpose: Treatment
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