Trial information
A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer
Status: Completed
Protocol number: MO16460
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of continuous Xeloda therapy in combination with irinotecan on treatment response in patients with advanced and/or metastatic colorectal cancer
Brief summary: This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
Target sample size is 50.
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. Tumor measurements (RECIST criteria) Time frame: Event driven
Key secondary outcomes: 1. Time to progression, time to response, duration of response, time to treatment failure, survival.
Time frame: Event driven
Inclusion criteria:
- adult patients >=18 years of age;
- locally advanced and/or metastatic colorectal cancer;
- >=1 target lesion.
Exclusion criteria:
- previous treatment with Xeloda or irinotecan;
- previous systemic therapy for metastatic disease;
- progressive disease during previous adjuvant therapy or within 6 months of completion.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Hoover, AL
- La Jolla, CA
- Washington, DC
- Miami, FL
- Boston, MA
- Albuquerque, NM
- New York, NY
- Charlotte, NC
- Providence, RI
- Memphis , TN
- Nashville, TN
