Roche trials database

Trial information

A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Colorectal Cancer

Status:

Completed

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 46.

Study phase:

II

Study type:

Interventional; Treatment; Non-randomized; Uncontrolled; Single group; Safety/efficacy study

Conditions:

• 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 Max: 75 years

Accepts healthy volunteers:

No

Anticipated start date:

August, 2008

Trial registration date:

29.05.2008

Date last updated:

12.06.2012

This trial was conducted at the following locations:

Taiwan

• KAOHSIUNG
• KUEISHAN
• TAICHUNG
• TAIPEI

Link to trial result