A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.
- Registration Number
- NCT00436241
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 capecitabine [Xeloda] - 1 Oxaliplatin -
- Primary Outcome Measures
Name Time Method Overall response rate Event driven
- Secondary Outcome Measures
Name Time Method Time to disease progression, overall survival, duration of response, time to response. Event driven AEs, laboratory parameters. Throughout study