Trial information
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum.
Status: No longer recruiting
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 (5mg/kg every 2 weeks or 7.5mg/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, and the target sample size is <100 individuals. Target sample size is
100.
Study phase: III
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. Safety: Serious and specific adverse events.
Key secondary outcomes: 1. Efficacy: Duration of survival; time to disease progression.
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: 06/21/2006
Date last updated: 11/18/2008
Link to trial result
This trial was conducted at the following locations:
Brazil
- Belo Horizonte
- Brasilia
- Campinas
- Caxias do Sul
- Curitiba
- Fortaleza
- Ijuí
- Porto Alegre
- Recife
- Ribeirão Preto
- Rio De Janeiro
- Salvador
- Sao Paulo
