Sorafenib in Combination With Irinotecan in Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors

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 monotherapy
  Intravenous infusion irinotecan 180 mg/m2 over 90 minutes (D1=D15) with cross over to irinotecan and sorafenib combination at progression.
• Active Comparator: Sorafenib monotherapy
  Oral sorafenib 400 mg twice daily (total dose 800 mg/day) with cross over to irinotecan and sorafenib combination at progression
• Experimental: Sorafenib and irinotecan combination
  Intravenous 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 ]