NCT00025350

Gefitinib in Treating Patients With Recurrent Metastatic Colorectal Cancer

A Randomized Phase II Trial of Two Dose Levels of ZD1839 (Iressa) (NSC 715055, IND 61187) in Patients With Recurrent Colorectal Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	gefitinib

Timeline

• Start date: 2001-10-01
• Completion: 2006-06-01
• First posted: 2003-10-22
• Last updated: 2013-06-24

Locations

16 sites across 1 country: United States