Sorafenib in Combination With Irinotecan in Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Study ID
- NCT01715441
- Phase
- PHASE2
- Status
- Completed
Conditions
- Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Sorafenib and irinotecan combination — DRUG
- Sorafenib monotherapy — DRUG
- Irinotecan monotherapy — DRUG
Study Details
The aim of this multicenter randomized phase II trial is to determine the efficacy of sorafenib and irinotecan combination versus irinotecan monotherapy or versus sorafenib monotherapy in metastatic colorectal cancer patients with KRAS mutated tumors after failure of all active drugs known to be effective.
Key Dates
- Start date
- Sep 30, 2012
- Status verified
- Feb 2026
- Primary completion
- Mar 31, 2015
- Completion
- Sep 30, 2015
Study Design
- Enrollment
- 173 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Irinotecan monotherapyIntravenous infusion irinotecan 180 mg/m2 over 90 minutes (D1=D15) with cross over to irinotecan and sorafenib combination at progression.
- Active Comparator: Sorafenib monotherapyOral sorafenib 400 mg twice daily (total dose 800 mg/day) with cross over to irinotecan and sorafenib combination at progression
- Experimental: Sorafenib and irinotecan combinationIntravenous infusion irinotecan 120 mg/m2 over 90 minutes (D1=D15) at Cycle 1, 150 mg/m² at C2 if no diarrhea \> grade 1 and no other toxicity \> grade 2, and 180 mg/m² at C3 in the same conditions * Oral sorafenib 400 mg twice daily (total dose 800 mg/day) from C1. 1 cycle = 15 days and 1 course = 4 weeks.
Primary Outcome Measure
Non-progression rate [ Time Frame: At 2 months ]