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: ML18559
Sponsor: Roche Products Ltd.
Company division: Pharmaceutical
Official Scientific Title: An open-label study of Avastin in combination with chemotherapy regimens as second-line treatment in patients with metastatic colon or rectal cancer
Brief summary: This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression, and the target sample size is <100 individuals.
Target sample size is 56.
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. Efficacy: Overall control of disease (defined as overall response rate plus stable disease, by RECIST criteria).
Key secondary outcomes: 1. Efficacy: Progression-free survival, overall response rate, duration of response, duration of overall control of disease, and overall survival Safety: Targeted adverse events
Inclusion criteria:
- patients with metastatic colon or rectal cancer, progressing or relapsing after first-line treatment;
- women of childbearing potential must use adequate contraception up to at least 6 months after the last dose of bevacizumab.
Exclusion criteria:
- Patients with metastatic colon or rectal cancer scheduled for a first-line systemic treatment;
- untreated brain metastases, spinal cord compression or primary brain tumours;
- pregnant or lactating women;
- major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start;
- treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2005
Trial registration date: 06/24/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
France
- Angers
- Besancon
- Boulogne-Billancourt
- Colmar
- Dijon
- La Roche Sur Yon
- Marseille
- Montpellier
- Neuilly-Sur-Seine
- Nice
- Paris
- Pierre Benite
- Reims
- Saint Herblain
- Toulouse
