Trial information
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
Status: Completed
Protocol number: MO18458
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of first-line treatment with Avastin combined with irinotecan and 5-fluorouracil on survival in patients with metastatic colorectal cancer
Brief summary: This study will evaluate the efficacy and safety of Avastin in combination with a standard chemotherapeutic regimen as first-line treatment in patients with metastatic colon or rectal cancer. The anticipated time on study treatment is until progression of disease or unacceptable toxicity and the target sample size is 100-500 individuals.
Target sample size is 200.
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: bevacizumab[Avastin]
Primary outcome: 1. Efficacy: Progression-free survival.
Key secondary outcomes: 1. Overall response rate, time to response, duration of response, overall survival, safety.
Inclusion criteria:
- adult patients >=18 years of age;
- recently diagnosed metastatic cancer of the colon or rectum;
- no prior systemic treatment for the metastatic disease;
- prior adjuvant treatment completed at least 6 months prior to treatment;
- diagnosis of metastatic disease <=3 months;
- measurable disease.
Exclusion criteria:
- adjuvant irinotecan or anti-VEGF treatment, or prior chemotherapeutic treatment for metastatic cancer of the colon or rectum;
- clinical evidence of brain metastases;
- major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment;
- ongoing need for full dose anticoagulants;
- uncontrolled hypertension;
- clinically significant cardiovascular disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Brisbane
- Melbourne
- Perth
- Port Macquarie
- Sydney
- Waratah
Canada
- Barrie, ON
- Newmarket, ON
- Sault Ste Marie, ON
China
Italy
Spain
