Gastric Cancer
Conditions
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.
Interventions
DRUGOxaliplatin
85mg/m2 iv on day 1 of each 2 week cycle
DRUGcapecitabine [Xeloda]
1000mg/m2 po bid on days 1-10 of each 2 week cycle
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | Event driven |
Secondary
| Measure | Time frame |
|---|---|
| AEs, laboratory parameters. | Throughout study |
| Time to disease progression, overall survival, duration of response, time to response. | Event driven |
Countries
Taiwan
Outcome results
None listed