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
- 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,
- 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
- 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
Masking: Open Label, Primary Purpose: Treatment
Chris H. Takimoto, MD, PhD
University of Texas Health Science Center at San Antonio
United States: Food and Drug Administration
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|Institute for Drug Development||San Antonio, Texas 78245-3217|