NCT00030524

ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer

A Phase II Clinical, Biological and Pharmacological Study of ZD1839 in Patients With Advanced Colorectal Carcinoma Refractory to 5-Fluorouracil (5-FU) and Irinotecan Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of colorectal cancer. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have locally advanced or metastatic colorectal cancer that has not responded to chemotherapy.

Detailed description

OBJECTIVES: * Determine the progression-free rate at 16 weeks, response rate, time to treatment failure, and survival of patients treated with gefitinib for locally advanced or metastatic colorectal adenocarcinoma that is refractory to fluorouracil, irinotecan, and capecitabine. * Correlate the pharmacodynamic effects of this drug with indices of clinical benefit (e.g., tumor growth inhibition, time to tumor progression, and survival) in these patients. * Determine whether the status of epidermal growth factor receptor activation and signaling are predictive of clinical outcome in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral gefitinib once daily. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 5-12 months.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	gefitinib

Timeline

• Start date: 2002-01-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2003-05-07
• Last updated: 2012-10-30

Locations

2 sites across 1 country: United States