Trial Information

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

Status: Recruiting

Protocol Number: MO18024

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: First-line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum. First BEAT (Bevacizumab Expanded Access Trial)

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. Target sample size is 2000.

Study Phase: IV

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Single Group
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Colorectal Cancer

Intervention Type: Drug

Intervention Name: bevacizumab[Avastin]

Primary Outcome: 1. Safety: Incidence of 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;
  • 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: 07/15/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Fremantle, Australia, 6160
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 21, 2008 at 2:20:56 PM


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