drugset / Trial / NCT00436241
A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-03
- Primary completion
- 2010-11
- Completion
- 2010-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |