NCT00003565

Docetaxel in Treating Patients With Solid Tumors

A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · 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. PURPOSE: Phase II trial to compare the effectiveness of docetaxel in treating Caucasian and African American patients who have solid tumors.

Detailed description

OBJECTIVES: * Compare the population pharmacokinetics of docetaxel in Caucasians and African American patients with solid tumors. * Compare the pharmacodynamic effect of a single dose of docetaxel in relation to hematological toxicity in these patient populations. * Determine the CYP3A4 genotype and P-glycoprotein (P-gp) expression and their relationship to docetaxel clearance in these patient populations. OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Patients may receive additional courses beginning 21 days after the first docetaxel dose at the discretion of the physician.

Conditions

• Bladder Cancer
• Breast Cancer
• Head and Neck Cancer
• Lung Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	docetaxel

Timeline

• Start date: 1998-09-01
• Primary completion: 2006-01-01
• Completion: 2008-01-01
• First posted: 2003-01-27
• Last updated: 2016-07-14

Locations

74 sites across 3 countries: United States, Canada, Puerto Rico