Trial information
A Study of Xeloda (Capecitabine) in Patients With Advanced or Metastatic Gastric Cancer
Status: No longer recruiting
Protocol number: ML17032
Sponsor: Roche Products Pty Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of first-line chemotherapy with Xeloda plus cisplatin versus 5-fluorouracil plus cisplatin on time to disease progression in patients with advanced or metastatic gastric cancer
Brief summary: This study will evaluate the efficacy and safety of oral Xeloda versus 5-fluorouracil, in combination with intravenous cisplatin, in patients with advanced and/or metastatic gastric cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is 300.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Gastric Cancer
Intervention type: Drug
Intervention name: capecitabine[Xeloda]
Primary outcome: 1. Efficacy: Non-inferiority, time to progression of disease, or death.
Key secondary outcomes: 1. Efficacy: Overall response rate, survival time, duration of response, and time to response Safety: Adverse events and laboratory tests
Inclusion criteria:
- adult patients, 18-75 years of age;
- advanced and/or metastatic gastric cancer;
- >=1 measurable lesion.
Exclusion criteria:
- uncontrolled infection;
- evidence of central nervous system metastases;
- history of another malignancy within the last 5 years except cured basal cell cancer of skin and cured in-situ cancer of uterine cervix;
- radiation therapy or major surgery within 4 weeks of treatment start;
- previous chemotherapy.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: April, 2003
Trial registration date: 08/31/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Argentina
Brazil
- Barretos
- Curitiba
- Florianopolis
- Fortaleza
- Porto Alegre
- Sao Paulo
- Sorocaba
China
- Beijing
- Guangdong
- Hong Kong
- Hubei
- Jiangsu
- Jiangxi
- Shandong
- Shanghai
- Suzhou
- Tianjin
Colombia
Guatemala
Korea, Republic of
Malaysia
Mexico
Peru
Russian Federation
- Kazan
- Moscow
- St Petersburg
Uruguay
Venezuela
