Gefitinib and Docetaxel in Treating Patients With Advanced Solid Tumors
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.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||March 2004|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
- 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.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Naiyer Rizvi, MD||Memorial Sloan-Kettering Cancer Center|
|Principal Investigator:||David B. Solit, MD||Memorial Sloan-Kettering Cancer Center|