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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine; Cisplatin; Fluorouracil

Criteria

Inclusion Criteria:

• Adults 18 to 75 years of age

• Advanced and/or metastatic gastric cancer with at least 1 measurable lesion

Exclusion Criteria:

• Uncontrolled infection

• Evidence of central nervous system (CNS) metastases

• History of other malignancy within the last 5 years, except cured basal cell cancer of the skin or cured in-situ cancer of the uterine cervix

• Radiation therapy or major surgery within 4 weeks of study drug

• Previous chemotherapy