drugset / Trial / NCT00012389

Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer

NCT00012389 ↗

Phase 3 Completed Sanofi
RandomizedOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if irinotecan is more effective with or without oxaliplatin in treating metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with or without oxaliplatin in treating patients who have metastatic colorectal cancer.

Timeline

Start
2000-12
Primary completion
—
Completion
2008-10

Outcome

Met primary endpoint

paper in the IROX and irinotecan groups, respectively (hazard ratio = 0.78; 95% CI, 0.65 to 0.94; P = .0072). PMID 18824706 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 200 mg/m2 Intravenous
Subject Irinotecan Small molecule 350 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous

Indications