Gefitinib in Treating Patients With Recurrent Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00025350
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of recurrent metastatic colorectal cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of gefitinib in treating patients who have recurrent metastatic colorectal cancer.
- Detailed Description
OBJECTIVES:
* Determine the 4-month progression-free survival rate in patients with recurrent metastatic colorectal adenocarcinoma treated with gefitinib.
* Determine the objective tumor response rate, progression, and overall survival of patients treated with this drug.
* Determine the toxicity of this drug in these patients.
OUTLINE: This is a randomized, double-blind study. Patients are stratified according to ECOG performance status (0-1 vs 2), baseline serum CEA (less than 5 mg/L vs at least 5 mg/L), and number of metastatic sites (1 vs 2 or more). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral gefitinib once daily (twice daily on day 1 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive a higher dose of oral gefitinib as in arm I. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago
🇺🇸Chicago, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Veterans Affairs Medical Center - New York
🇺🇸New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Scroll for more (6 remaining)Robert H. Lurie Comprehensive Cancer Center, Northwestern University🇺🇸Chicago, Illinois, United States