Phase I Study Of Flavopiridol And Docetaxel (Taxotere) In Patients With Advanced Cancers
- Determine the dose-limiting toxic effects and maximum tolerated dose of flavopiridol
and docetaxel in patients with advanced solid tumors.
- Determine the objective response rate and duration of response in patients treated with
- Determine the pharmacokinetics of these drugs in this patient population.
OUTLINE: This is a dose-escalation study.
Patients receive docetaxel IV over 60 minutes on day 1 and flavopiridol IV continuously over
24 hours on day 2. Treatment repeats every 3 weeks in the absence of disease progression or
Cohorts of 3-6 patients receive escalating doses of docetaxel and flavopiridol until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 9-11
Primary Purpose: Treatment
Philip A. Philip, MD, PhD, FRCP
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|