Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

OBJECTIVES:

• 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 annually thereafter.

PROJECTED ACCRUAL: A total of 6-56 patients will be accrued for this study.