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

Roche

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Oxaliplatin; Drug: capecitabine [Xeloda]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00436241

ML20734

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Oxaliplatin

Drug: capecitabine [Xeloda]