Trial information
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
Status: Completed
Protocol number: ML18017
Sponsor: Roche Bulgaria EOOD
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the safety, tolerability, and response rate of Xeloda in treatment-naïve patients with metastatic colorectal cancer
Brief summary: This study will evaluate the efficacy, safety, and pharmacoeconomics of oral Xeloda in patients with 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 28.
Study phase: IV
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. Safety: Adverse events. Efficacy: Response rate, ie, percentage of patients with complete, partial, and overall response
Key secondary outcomes: 1. Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings
Inclusion criteria:
- adult patients >=18 years of age;
- metastatic colorectal cancer.
Exclusion criteria:
- previous cytotoxic chemotherapy or immunotherapy for advanced or metastatic disease;
- central nervous system and bone metastases;
- moderate or severe renal impairment;
- clinically significant cardiac disease;
- lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication;
- malignancy within the last 5 years, except cured basal cell cancer of skin and cured 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: 10/27/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Bulgaria
- Plovdiv
- Sofia
- Stara Zagora
