A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer

Phase 3 Completed 316 enrolled Hoffmann-La Roche

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus 5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at least 6 weeks and continued up to disease progression, and the target sample size is 300 individuals.

Timeline

Start: 2003-04
Primary completion: 2010-08
Completion: 2010-08

Outcome

Met primary endpoint

paper The adjusted hazard ratio (HR) for PFS was 0.52 (95% confidence interval [CI]: 0.32-0.83, P = 0.006). PMID 29372626 ↗

Publications

Chen J, Xiong J, Wang J, Zheng L, Gao Y, Guan Z. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin in Chinese patients with advanced and metastatic gastric cancer: Re-analysis of efficacy and safety data from the ML17032 phase III clinical trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e310-e316. doi: 10.1111/ajco.12832. Epub 2018 Jan 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Cisplatin	Other / unclassified	80 mg/m2	Intravenous
Comparator	fluorouracil	Small molecule	800 mg/m2	Intravenous