drugset / Trial / NCT00037180

For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy

NCT00037180 ↗

Phase 2 Terminated 212 enrolled Pfizer
RandomizedParallel-groupDouble-blindTreatment

Summary

The Diarrhea Prevention with an investigational drug trial, will evaluate whether adding an investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. The standard and approved treatment for patients with metastatic colorectal cancer is repeated cycles of chemotherapy consisting of a combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as 5FU), and leucovorin (also known as LV). Preclinical data from animal models suggest that the investigational drug may offer an effective means for preventing CPT-11/5FU/LV-induced diarrhea. It is also hypothesized that the investigational drug-mediated anti-angiogenesis could induce a favorable tumor response.

Timeline

Start
2002-04
Primary completion
—
Completion
2003-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Celecoxib Other / unclassified — —
Background Irinotecan Small molecule — —
Background Leucovorin Small molecule — —
Background fluorouracil Small molecule — —