drugset / Trial / NCT00511446

Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer

NCT00511446 ↗

Phase 2 Completed 56 enrolled Martin-Luther-University Halle-Wittenberg
NaSingle-groupOpen-labelTreatment

Summary

Combination regimens of 3 active drugs have shown promising activity in treatment of metastatic gastric cancer. Docetaxel combined with cisplatin and 5-fluorouracil (FU) yielded superior overall survival and response rates when compared to standard cisplatin and 5-FU. However, a toxicity profile showed the need for development of less toxic modifications. In a prior phase I trial, the maximum tolerated dose was defined. In this phase II trial, a first evaluation of activity will be performed.

Timeline

Start
2007-08
Primary completion
2010-05
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 800 mg/m2 Oral
Subject Docetaxel Small molecule 35 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 70 mg/m2 Intravenous

Indications