Gefitinib in Treating Patients With Recurrent Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00025350|
Recruitment Status : Completed
First Posted : October 22, 2003
Last Update Posted : June 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: gefitinib||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Randomized Phase II Trial of Two Dose Levels of ZD1839 (Iressa) (NSC 715055, IND 61187) in Patients With Recurrent Colorectal Adenocarcinoma|
|Study Start Date :||October 2001|
|Actual Study Completion Date :||June 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025350
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Veterans Affairs Medical Center - Lakeside Chicago|
|Chicago, Illinois, United States, 60611|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62526|
|CCOP - Evanston|
|Evanston, Illinois, United States, 60201|
|United States, Michigan|
|CCOP - Kalamazoo|
|Kalamazoo, Michigan, United States, 49007-3731|
|United States, New Jersey|
|Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, New York|
|Veterans Affairs Medical Center - New York|
|New York, New York, United States, 10010|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|United States, North Dakota|
|CCOP - Merit Care Hospital|
|Fargo, North Dakota, United States, 58122|
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213-3489|
|United States, Tennessee|
|Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus|
|Nashville, Tennessee, United States, 37212|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|United States, Wisconsin|
|Veterans Affairs Medical Center - Madison|
|Madison, Wisconsin, United States, 53705|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-6164|
|Study Chair:||Mace L. Rothenberg, MD, FACP||Vanderbilt-Ingram Cancer Center|