Trial information
A Study of the Efficacy and Tolerability of Xeloda (Capecitabine) in First-Line and Second-Line Therapy in Patients With Metastatic Colorectal Cancer
Status: Completed
Protocol number: M66020
Sponsor: Hoffmann-La Roche AG
Company division: Pharmaceutical
Official Scientific Title: An open-label study to analyze the effect on response and disease progression of capecitabine (Xeloda) in metastatic colorectal cancer patients with regard to the expression profile of key enzymes in the capecitabine metabolism
Brief summary: This study will evaluate the efficacy and tolerability of Xeloda in patients with metastatic colorectal cancer. Patients will receive oral Xeloda as first-line therapy; in patients with relapse during first-line therapy, capecitabine plus intravenous oxaliplatin will be given as second-line therapy. Treatments may be extended or terminated based on disease status. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 80.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: capecitabine [Xeloda]
Primary outcome: 1. Objective response rate, time to response, duration of response, time to disease progression or death, and overall survival.
Key secondary outcomes: 1. Efficacy, tolerability with respect to expression of key enzymes in primary and metastatic tumors.
Inclusion criteria:
- adult patients >=18 years of age;
- metastatic colorectal cancer;
- >= 1 measurable lesion;
- no prior treatment, except adjuvant therapy with 5-flourouracil/leucovorin discontinued >=6 months before study.
Exclusion criteria:
- previous treatment with Xeloda;
- organ transplant;
- clinically significant cardiac disease;
- history of another malignancy within last 5 years, except cured basal cell cancer of skin and cancer in situ of uterine cervix.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 03/10/2006
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Germany
- Berlin
- Magdeburg
- Mönchengladbach
