A Phase II Trial Of IRESSA (NSC 715055, IND 61187) In Combination With 5-FU/LV/ CPT-11 In Patients With Advanced Or Recurrent Colorectal Cancer
I. Determine the safety of gefitinib, fluorouracil, leucovorin calcium, and irinotecan in
patients with advanced or recurrent colorectal cancer.
II. Determine the major side effects of this regimen in these patients. III. Determine the
response rate, progression-free survival, and overall survival of patients treated with this
IV. Correlate response and other measures of outcome with epidermal growth factor receptor
expression and the expression of genes that impact upon pathways of fluoropyrimidine
cytotoxicity in patients treated with this regimen.
OUTLINE: This is a non-randomized, open-label, multi-center study.
Patients receive oral gefitinib daily beginning on day 1, irinotecan IV over 90 minutes on
days 1 and 15, and leucovorin calcium IV over 2 hours and fluorouracil IV over 3-5 seconds
followed by a 22-hour infusion on days 1, 2, 15, and 16. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Grade 3 or 4 toxicity, graded using the NCI CTC version 2.0
Up to 2 years
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|