Trial Information

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

Status: Completed

Protocol Number: MO18458

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the effect of first-line treatment with Avastin combined with irinotecan and 5-fluorouracil on survival in patients with metastatic colorectal cancer

Brief Summary: This study will evaluate the efficacy and safety of Avastin in combination with a standard chemotherapeutic regimen as first-line treatment in patients with metastatic colon or rectal cancer. The anticipated time on study treatment is until progression of disease or unacceptable toxicity and the target sample size is 100-500 individuals. Target sample size is 200.

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. Efficacy: Progression-free survival.

Key Secondary Outcomes: 1. Overall response rate, time to response, duration of response, overall survival, safety.

Inclusion Criteria:

  • adult patients >=18 years of age;
  • recently diagnosed metastatic cancer of the colon or rectum;
  • no prior systemic treatment for the metastatic disease;
  • prior adjuvant treatment completed at least 6 months prior to treatment;
  • diagnosis of metastatic disease <=3 months;
  • measurable disease.

Exclusion Criteria:

  • adjuvant irinotecan or anti-VEGF treatment, or prior chemotherapeutic treatment for metastatic cancer of the colon or rectum;
  • clinical evidence of brain metastases;
  • major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment;
  • ongoing need for full dose anticoagulants;
  • uncontrolled hypertension;
  • clinically significant cardiovascular disease.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 06/24/2005

Date Last Updated: 07/15/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Perth, Australia, 6000
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 21, 2008 at 2:14:22 PM


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