Status:
COMPLETED
A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 n...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00436241
Start Date
March 1 2007
End Date
November 1 2010
Last Update
November 2 2016
Active Locations (13)
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1
Chai Yi, Taiwan, 613
2
Chai Yi, Taiwan, 622
3
Kaohsiung City, Taiwan, 807
4
Keelung, Taiwan, 204