Trial information
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
Status: Completed
Protocol number: ML16987
Sponsor: Roche SAS
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study comparing the effect of Xeloda plus intravenous Eloxatin (Xelox) with the standard combination treatment regimen of 5-fluorouracil, folinic acid, and Eloxatin on tumor response in treatment-naïve patients with metastatic colorectal cancer
Brief summary: This study will compare the efficacy and safety of oral Xeloda plus intravenous Eloxatin (Xelox) with a standard treatment regimen as first line treatment in patients with metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is 304.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: capecitabine[Xeloda]
Primary outcome: 1. Best tumor response according to RECIST criteria
Key secondary outcomes: 1. Tumor response, survival without disease progression, overall survival, time to best response, response duration, and time to treatment failure. Safety: Evaluation of adverse events, clinical and laboratory parameters
Inclusion criteria:
- adult patients >=18 years of age;
- metastatic colorectal cancer;
- >=1 measurable lesion.
Exclusion criteria:
- previous immunotherapy;
- capecitabine, oxaliplatin, or 5-fluorouracil (5-FU) within the past 6 months;
- history of another malignancy during the last 5 years other than cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix;
- serious concomitant infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 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:
France
- Aubagne
- Beziers
- Bordeaux
- Brive
- Caen
- Clermont-Ferrand
- Colmar
- Creteil
- Ermont
- Grenoble
- La Roche Sur Yon
- Le Kremlin-Bicetre
- Lille
- Lorient
- Lyon
- Montpellier
- Paris
- Perigueux
- Rouen
- Saint Herblain
- Saint Nazaire
- Saint-Cloud
- Strasbourg
- Toulouse
- Vandoeuvre-Les-Nancy
- Villejuif
- Villeneuve Saint-Georges
