Trial information
A Study of Xeloda (Capecitabine) and PEGASYS in Treatment-Naive Patients With Advanced Liver Cancer
Status: No longer recruiting
Protocol number: ML18269
Sponsor: Roche Thailand Ltd
Company division: Pharmaceutical
Official Scientific Title: An open-label study of Xeloda in combination with Pegasys on overall treatment response in treatment-naïve patients with advanced liver cancer
Brief summary: This study will evaluate the efficacy and safety of Xeloda in combination with Pegasys in patients with advanced liver cancer who have had no prior treatment. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
Target sample size is 43.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Liver Cancer
Intervention type: Drug
Intervention name: capecitabine[Xeloda]
Primary outcome: 1. Objective response rate
Key secondary outcomes: 1. Efficacy: Time to disease progression, duration of response, and overall survival.
Safety: Adverse events and laboratory tests
Inclusion criteria:
- adults patients 18-75 years of age;
- locally advanced or metastatic liver cancer;
- measurable disease;
- not eligible for any standard therapy.
Exclusion criteria:
- previous treatment for liver cancer;
- main portal vein involvement;
- bone, brain, or leptomeningeal metastasis;
- history of clinically significant cardiac disease;
- lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome;
- history of cancer, except basal cell skin cancer or in situ cancer of the cervix.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: January, 2005
Trial registration date: 09/26/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Taiwan
