Trial information
A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.
Status: Recruiting
Protocol number: ML20734
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A open label study of the effect of first-line therapy with Xeloda in combination with oxaliplatin on overall response rate in patients with locally advanced and/or metastatic gastric cancer
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. Target sample size is 42.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Gastric Cancer
Intervention type: Drug
Intervention name: capecitabine [Xeloda]
Primary outcome: 1. Overall response rate Time frame: Event driven
Key secondary outcomes: 1. Time to disease progression, overall survival, duration of response, time to response. Time frame: Event driven
2. AEs, laboratory parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: March, 2007
Trial registration date: 02/16/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Taiwan
- Chai Yi
- Kaohsiung
- Keelung
- Taichung
- Tainan
- Taipei
- Taoyuan
- Yilan
