A Randomized Phase II Trial of Two Dose Levels of ZD1839 (Iressa) (NSC 715055, IND 61187) in Patients With Recurrent Colorectal Adenocarcinoma
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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Mace L. Rothenberg, MD, FACP
Study Chair
Vanderbilt-Ingram Cancer Center
United States: Federal Government
CDR0000068952
NCT00025350
October 2001
June 2006
Name | Location |
---|---|
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
CCOP - Evanston | Evanston, Illinois 60201 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
Veterans Affairs Medical Center - New York | New York, New York 10010 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | Nashville, Tennessee 37212 |