Prostate Cancer Clinical Trial
Official title:
A Phase I Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Refractory Neoplasms
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of flavopiridol in treating patients who
have refractory cancer.
OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of
flavopiridol in patients with refractory solid tumors or lymphoma. 2. Determine the
pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients receive flavopiridol IV over 1 hour on
day 1. Treatment continues every 3 weeks in the absence of disease progression. A cohort of
3-6 patients receives treatment at each dose level of flavopiridol. If dose-limiting
toxicity (DLT) occurs in no more than 1 of 6 patients, subsequent cohorts of 6 patients each
receive escalating doses of drug on the same schedule. Intrapatient dose escalation to the
next level is permitted in the absence of DLT.
PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study within 27
months.
;
Primary Purpose: Treatment
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