Trial information
A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Colorectal Cancer
Status: Recruiting
Protocol number: ML21209
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to assess the resection rate of liver metastases following neoadjuvant therapy with Avastin in combination with oxaliplatin and capecitabine (XELOX) in patients with metastatic colorectal cancer with unresectable liver metastasis
Brief summary: This single arm study will assess the resection rate of liver metastasis, time to disease progression, and safety of neoadjuvant treatment with Avastin in combination with oxaliplatin and capecitabine (XELOX) in patients with metastatic colorectal cancer with unresectable liver metastasis. Patients will receive Avastin 5mg/kg iv on day 1 of every 2 week cycle, oxaliplatin 85mg/m2 iv on day 1 of every 2 week cycle, and capecitabine 1000mg/m2 on days 1-5 and 8-12 of every 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is
45.
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: bevacizumab [Avastin]
Primary outcome: 1. Resection of liver metastasis after neoadjuvant treatment Time frame: Event driven
Key secondary outcomes: 1. Progression-free survival; time to disease progression Time frame: Event driven
2. SAEs, specific adverse events Time frame: Throughout study
Inclusion criteria:
- adult patients, <=75 years of age;
- chemotherapy-naive for stage IV colorectal cancer with unresectable liver metastasis;
- >=1 measurable lesion;
- ECOG status 0-2.
Exclusion criteria:
- prior exposure to Avastin;
- clinical or radiological evidence of CNS metastases;
- uncontrolled hypertension, or clinically significant cardiovascular disease;
- ongoing treatment with aspirin (>325mg/day) or other medications known to predispose to gastrointestinal ulceration.
Gender: Males or Females
Age limits: Min: N/A (No limit) Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 06/16/2008
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Taiwan
- Chai Yi
- Kaohsiung
- Kueishan
- Taichung
- Taipei
