Roche trials database

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:

ML20552

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

An Expanded Access Program of Avastin in patients with metastatic cancer of colon or rectum - Brazilian extension study

Brief summary:

This expanded access study will assess the efficacy and safety of intravenous Avastin (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment of patients with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months. Target sample size is 163.

Study phase:

III

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. Safety: Serious and specific adverse events Time frame: 12 months

Key secondary outcomes:

1. Efficacy: Duration of survival Time frame: 12 months
2. Efficacy: Time to disease progression Time frame: 12 months

Inclusion criteria:

• Previously untreated metastatic colon or rectal cancer;
• Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment.

Exclusion criteria:

• Prior chemotherapy for metastatic colon or rectal cancer;
• Planned radiotherapy for underlying disease;
• central nervous system metastases;
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before study start.

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Anticipated start date:

May, 2006

Trial registration date:

06.06.2006

Date last updated:

17.08.2010

This trial was conducted at the following locations:

Brazil

• BELO HORIZONTE
• BRASILIA
• CAMPINAS
• CAXIAS DO SUL
• CURITIBA
• FORTALEZA
• IJUI
• JOAO PESSOA
• PORTO ALEGRE
• RECIFE
• RIBEIRAO PRETO
• RIO DE JANEIRO
• SALVADOR
• SAO PAULO

Link to trial result