Spots Global Cancer Trial Database for Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors

Official Title: Phase I Study Of Flavopiridol And Docetaxel (Taxotere) In Patients With Advanced Cancers

Study ID: NCT00016185

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

alvocidib

docetaxel

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol and docetaxel in treating patients who have advanced solid tumors.

Detailed Description: OBJECTIVES: * 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 this regimen. * 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 unacceptable toxicity. 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 months.