drugset / Trial / NCT00230399

Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer

NCT00230399 ↗

Phase 2 Completed 15 enrolled University of Michigan Rogel Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.

Timeline

Start
2003-06
Primary completion
2006-01
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule — —
Subject Celecoxib Other / unclassified — —
Subject Irinotecan Small molecule — —

Indications