Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Swiss Cancer Institute
OBJECTIVES: Primary * Determine the maximum tolerated dose and recommended phase II dose of capecitabine administered in combination with oxaliplatin and irinotecan in patients with unresectable advanced or metastatic colorectal cancer. (Phase I) * Determine the efficacy of this regimen in these patients. (Phase II) Secondary * Determine the tolerability of this regimen in these patients. (Phase II) OUTLINE: This is a multicenter, phase I dose-escalation study of capecitabine followed by a phase II study. * Phase I: Patients receive oxaliplatin IV over 2 hours on days 1 and 15, irinotecan IV over 1 hour on days 8 and 22, and oral capecitabine twice daily on days 1-29. Treatment repeats every 5 weeks for up to 6 courses 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 capecitabine at the MTD and irinotecan and oxaliplatin as in phase I. After completion of study treatment, patients are followed every 2 months for 1 year and then every 4 months thereafter. PROJECTED ACCRUAL: A total of 23-32 patients (3-12 for the phase I portion and 20 for the phase II portion) will be accrued for this study within 2.75 years
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
