NCT00016185

Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	alvocidib
DRUG	docetaxel

Timeline

• Start date: 2001-03-01
• Primary completion: 2003-02-01
• Completion: 2005-12-01
• First posted: 2003-01-27
• Last updated: 2013-04-05

Locations

1 site across 1 country: United States