A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will assess the efficacy and safety of Xeloda in combination with oxaliplatin as first-line chemotherapy in patients with advanced and/or metastatic gastric cancer who have had no prior chemotherapy for advanced or metastatic disease. Eligible patients will receive Xeloda 1000mg/m2 po twice daily, D1-D10 every 2 weeks (10 days treatment followed by 4 days rest period) plus oxaliplatin 85 mg/m2/day iv, D1 every 2 weeks. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• gastric cancer with unresectable locally advanced and/or metastatic disease;

• >=1 measurable lesion;

• ambulatory, with ECOG Performance Status >=1.

Exclusion Criteria:

• previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to enrollment);

• clinically significant cardiac disease or myocardial infarction within last 12 months;

• CNS metastases;

• history of other malignancy within last 5 years, except for cured basal cell cancer of the skin, or in situ cancer of the cervix.