Colorectal Cancer 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
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.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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