A Phase I Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Refractory Neoplasms
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.
Interventional
Primary Purpose: Treatment
Edward A. Sausville, MD, PhD
Study Chair
National Cancer Institute (NCI)
United States: Federal Government
CDR0000065779
NCT00019344
August 1997
Name | Location |
---|---|
Medicine Branch | Bethesda, Maryland 20892 |