drugset / Trial / NCT00249977

Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan

NCT00249977

Phase 1 Completed 21 enrolled University of New Mexico
Non-randomizedSingle-groupOpen-labelTreatment

Summary

1. To determine the safety and feasibility of administering Capecitabine with the combination of Cisplatin and Irinotecan. 2. To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan. 3. To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy.

Timeline

Start
2003-04
Primary completion
2007-08
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule Oral
Background Cisplatin Other / unclassified 50 mg/m2
Background Irinotecan Small molecule 50 mg/m2

Indications