A Phase I/II Study of Capecitabine (XELODA®, Roche) Plus Oxaliplatin (Eloxatin®, Sanofi) Plus ZD 1893 (IRESSA®) in the Treatment of Metastatic Colorectal Cancer
- Determine the maximum tolerated dose of capecitabine when given in combination with
oxaliplatin and gefitinib in patients with metastatic colorectal cancer. (phase I)
- Determine the response rate in patients treated with this regimen. (phase II)
- Determine the safety and toxic effects of this regimen in these patients.
- Determine the 1-year survival of patients treated with this regimen. (phase II)
- Determine the progression-free and overall survival of patients treated with this
regimen. (phase II)
OUTLINE: This is an open-label, nonrandomized, phase I, dose-escalation study of
capecitabine followed by a phase II study.
- Phase I: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV
over 2 hours on day 1. Patients also receive oral gefitinib once daily beginning 5 days
before the initiation of capecitabine and oxaliplatin and continuing for the duration
of study treatment. Courses repeat every 21 days in the absence of disease progression
or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive oral capecitabine (at the MTD determined in phase I),
oxaliplatin IV, and oral gefitinib as in phase I.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I portion of this
study within 1-12 months; and a total of 26 patients will be accrued for the phase II
portion of this study within 8-13 months.
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
Marwan Fakih, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|