Trial information
A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.
Status: No longer recruiting
Protocol number: ML20777
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of first line treatment with Xeloda in combination with chemotherapy on safety and treatment response in patients with advanced and/or metastatic gastric cancer suitable for treatment with a fluoropyrimidine-based regimen.
Brief summary: This single arm study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the chemotherapy regimen used. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is
157.
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. Safety profile, specifically incidence of hand-foot syndrome Time frame: Throughout study
Key secondary outcomes: 1. Time to response, duration of response, overall response rate, survival time. Time frame: Event driven
Inclusion criteria:
- adult patients, >=18 years of age;
- advanced or metastatic gastric cancer;
- ECOG <=2.
Exclusion criteria:
- previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to study);
- evidence of CNS metastasis;
- history of another malignancy within the last 5 years (except for successfully treated basal cell cancer of skin, or in situ cancer of the cervix);
- clinically significant cardiac disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2007
Trial registration date: 03/29/2007
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Spain
- Alcorcon
- Alcoy
- Barcelona
- Bilbao
- Burgos
- Cádiz
- Castellon
- Córdoba
- Girona
- Granada
- Huesca
- Jaen
- La Coruna
- Lleida
- Logroño
- Lugo
- Madrid
- Murcia
- Navarra
- Palencia
- Palma de Mallorca
- Pamplona
- Puerto Real
- Salamanca
- San Sebastian
- Santa Cruz de Tenerife
- Santiago de Compostela
- Sevilla
- Toledo
- Valencia
- Vigo
