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

Trial Information

Status: No longer recruiting

Protocol Number: MO18024

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An expanded-access study of the safety of Avastin in patients with colorectal cancer

Brief Summary: This expanded access study will evaluate the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as first-line treatment for metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

Study Phase: IV

Study Design / Study Details:

Purpose: Treatment

Allocation: Non-Randomized

Masking: Open Label

Control: Uncontrolled

Assignment: Expanded Access

Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Colorectal Cancer

Intervention Type: Drug

Intervention Name: bevacizumab [Avastin]

Primary Outcome: Safety: Incidence of serious and specific adverse events

Key Secondary Outcomes: 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;

women of childbearing potential must have a negative serum pregnancy test within 7 days prior to study entry;

women of childbearing potential must use adequate contraception up to at least 6 months after last treatment completion, or the last drug dose, whichever occurs first.

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 prior to start of study;

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

Accepts Healthy Volunteers: No

Anticipated Start Date: June, 2004

Trial Registration Date: 06/24/2005

Date Last Updated: 06/25/2007