A Phase I Dose Escalation of ZD1839 (Iressa®) (Days 1 and 2) and Docetaxel (Day 3) Every 3 Weeks in Patients With an Advanced Solid Tumor
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Locations
- 1
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die. Giving gefitinib with docetaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib when given with docetaxel in treating patients with advanced solid tumors.
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of gefitinib when administered with docetaxel in patients with advanced solid tumors. * Determine the safety and efficacy of this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation study of gefitinib. Patients receive oral gefitinib once daily on days 1 and 2 and docetaxel IV over 1 hour on day 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 3-42 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified