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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug | 85mg/m2 iv on day 1 of each 2 week cycle |
| |
| capecitabine [Xeloda] |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Event driven |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression, overall survival, duration of response, time to response. | Event driven | |
| AEs, laboratory parameters. | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chai Yi | 613 | Taiwan | ||||
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| Drug |
1000mg/m2 po bid on days 1-10 of each 2 week cycle |
|
| Chai Yi |
| 622 |
| Taiwan |
| Kaohsiung City | 807 | Taiwan |
| Keelung | 204 | Taiwan |
| Taichung | 404 | Taiwan |
| Taichung | 407 | Taiwan |
| Tainan | 704 | Taiwan |
| Tainan | 710 | Taiwan |
| Taipei | 00112 | Taiwan |
| Taipei | 106 | Taiwan |
| Taipei | 110 | Taiwan |
| Taoyuan | 333 | Taiwan |
| Yilan | 265 | Taiwan |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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