Trial information
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer
Status: No longer recruiting
Protocol number: ML18469
Sponsor: Roche Products Ltd.
Company division: Pharmaceutical
Official Scientific Title: A single-arm, open-label study of Avastin plus Xeloda on objective treatment response in patients with advanced or metastatic liver cancer who have had no previous cytotoxic chemotherapy
Brief summary: This study will evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin in patients with advanced or metastatic liver cancer. The anticipated time on study treatment is 3-12 months, 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: bevacizumab[Avastin]
Primary outcome: 1. Objective response rate through tumor measurement and assessment
Key secondary outcomes: 1. Disease control rate (complete response plus partial response plus stable disease), time to disease progression, and overall survival . Safety profile
Inclusion criteria:
- adult patients >=18 years of age;
- advanced or metastatic liver cancer;
- >=1 measurable lesion.
Exclusion criteria:
- current radiotherapy, chemotherapy, or other experimental therapies;
- prior cytotoxic chemotherapy;
- major surgery, open biopsy, or traumatic injury within 28 days of study entry;
- history of a malignancy during the last 5 years, other than cutaneous basal cell cancer or in situ cervical cancer.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2005
Trial registration date: 08/29/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
China
Singapore
Taiwan
