drugset / Trial / NCT00142038

Docetaxel and Capecitabine in Advanced Gastric Cancer

NCT00142038 ↗

Phase 2 Completed 80 enrolled Charite University, Berlin, Germany
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Up to date there is no worldwide accepted standard chemotherapy for the 1st-line treatment of advanced or metastatic gastric cancer.A combination of epirubicin, cisplatin and 5-FU (ECF) is the best examined combination and widely used. Recent studies (Thuss-Patience et al, J. Clin. Oncol. 2005) could show that a combination of docetaxel and 5-FU might be similarly effective as ECF. 5-FU and docetaxel +/- cisplatin combinations are investigated by many groups and may be a future reference treatment. Many data suggest that 5-FU infusion can be replaced by oral capecitabine with equal efficacy. As docetaxel/5-FU is probably similarly effective as epirubicin/cisplatin/5-FU and a replacement of 5-FU infusion by capecitabine makes the chemotherapy more comfortable for the patient we investigate in this study a chemotherapy of docetaxel and capecitabine as 1st-line therapy for metastatic or advanced gastric cancer.

Timeline

Start
2004-03
Primary completion
—
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 800 mg/m2 Oral
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Docetaxel Small molecule 60 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous