A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: Oxaliplatin; Drug: capecitabine [Xeloda]

• 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

Study Timeline

• Study First Submitted: 2007-02-16
• Study First Submitted QC: 2007-02-16
• Study First Posted: 2007-02-19
• Study Start: 2007-03
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

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