A Phase I/II Study to Determine the Safety and Efficacy of Second-Line Treatment With XELOX Plus Gemcitabine in Irinotecan Pre-Treated Advanced Colorectal Cancer Patients
- Define the dose-limiting toxicity and maximum tolerated dose of gemcitabine
hydrochloride when administered with capecitabine and oxaliplatin as second-line
therapy in patients with advanced colorectal cancer previously treated with irinotecan
hydrochloride. (Phase I)
- Determine the recommended phase II dose of gemcitabine hydrochloride in these patients.
- Assess overall response rate in patients treated with this regimen. (Phase II)
- Assess the progression-free survival of patients treated with this regimen. (Phase II)
- Assess the time to treatment failure, duration of response, and time to response in
patients treated with this regimen. (Phase II)
- Assess the overall survival of patients treated with this regimen. (Phase II)
- Assess the safety of this regimen in these patients. (Phase II)
OUTLINE: This is a multicenter, phase I, dose-escalation study of gemcitabine hydrochloride,
followed by a phase II, open-label study.
- Phase I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8,
oral capecitabine twice daily on days 1-14, and oxaliplatin IV over 2 hours on day 1.
Courses repeat every 21 days.
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride until the
maximum tolerated dose (MTD) is determined.
- Phase II: Patients receive gemcitabine hydrochloride at the MTD determined in phase I
and capecitabine and oxaliplatin as in phase I.
Masking: Open Label, Primary Purpose: Treatment
Overall response rate as assessed by RECIST criteria
Joong B. Ahn, MD