Overview

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