Roche trials database

Trial information

A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

Status:

Completed

Protocol number:

ML18559

Sponsor:

Hoffmann-La Roche

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. Target sample size is 54.

Study phase:

II

Study type:

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

Conditions:

• Colorectal Cancer

Primary outcome:

1. Efficacy: Overall control of disease (defined as overall response rate plus stable disease, by RECIST criteria) Time frame: 9 months

Key secondary outcomes:

1. Progression-free survival Time frame: 9 months
2. Overall response rate Time frame: 9 months
3. Duration of response Time frame: 9 months
4. Duration of overall control of disease Time frame: 9 months
5. Overall survival Time frame: 9 months
6. Safety profile of Avastin Time frame: 9 months

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:

21.12.2005

Date last updated:

10.06.2013

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-CLOUD
• SAINT HERBLAIN
• TOULOUSE

Link to trial result