Single Center Open-Label Non-Comparative Phase I Dose Finding Study Of Weekly Flavopiridol In Combination With Weekly Docetaxel In Patients With Advanced Solid Tumors
- Determine the maximum tolerated dose of flavopiridol when administered in combination
with 2 different doses of docetaxel in patients with advanced solid tumors.
- Determine the clinical pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the therapeutic activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of flavopiridol.
Patients receive docetaxel IV over 30 minutes followed at least 4 hours later by
flavopiridol IV over 1 hour on days 1, 8, and 15. Courses repeat every 4 weeks in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 6 patients experience dose-limiting toxicity. Separate MTDs of flavopiridol are
determined when flavopiridol is combined with 2 different doses of docetaxel. A total of 10
patients are treated at each flavopiridol MTD.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then
PROJECTED ACCRUAL: A total of 6-56 patients will be accrued for this study.
Primary Purpose: Treatment
Gary K. Schwartz, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
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