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
Sanofi
OBJECTIVES: * Compare the overall survival of patients with metastatic colorectal cancer treated with irinotecan with or without oxaliplatin. * Compare the response rate, time to tumor-related worsening of symptoms, time to disease progression, onset and duration of responses, and duration of disease stabilization in these patients treated with these regimens. * Compare the safety of these regimens in these patients. OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs involved (1 vs 2 or more), lactic dehydrogenase (no greater than 1.5 times upper limit of normal (ULN) vs greater than 1.5 times ULN), and prior fluorouracil chemotherapy (adjuvant vs first-line treatment for metastatic disease). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive irinotecan IV over 90 minutes on day 1. * Arm II: Patients receive oxaliplatin IV over 120 minutes followed by irinotecan IV over 30 minutes on day 1. Courses repeat in each arm every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days, every 4 weeks for 3 months, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 596 patients (298 per arm) will be accrued for this study within 18 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
