Trial Information

Summary: A Study of Avastin (Bevacizumab) Added to Various Chemotherapy Regimens in Patients With Colon Cancer

Status: No longer recruiting

Protocol Number: BO17920

Sponsor: F. Hoffmann-La Roche AG/Roche Global Development

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of Avastin in combination with either capecitabine plus oxaliplatin (Xelox) or fluorouracil/leucovorin with oxaliplatin (Folfox-4) on disease-free survival in patients with colon cancer

Brief Summary: This study will evaluate the efficacy and safety of Avastin added to various combination regimens as adjuvant chemotherapy in chemotherapy-naive patients with colon cancer, who have had surgery. The anticipated time of study treatment is 6-12 months, and the target sample size is 500+ individuals. Target sample size is 3450.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Colorectal Cancer

Intervention Type: Drug

Intervention Name: bevacizumab[Avastin]

Primary Outcome: 1. Disease-free survival

Key Secondary Outcomes: 1. Efficacy: Overall survival. Safety: Adverse events and laboratory abnormalities.

Inclusion Criteria:

  • adult patients;
  • >=18 years of age;
  • documented colon carcinoma;
  • not a candidate for (neo) adjuvant radiotherapy;
  • curative surgery not less than 4 and not more than 8 weeks prior to study randomization.

Exclusion Criteria:

  • evidence of metastatic disease;
  • previous anti-angiogenic treatment for any malignancy;
  • previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer;
  • pregnant or lactating women;
  • fertile men, or women of childbearing potential, not using adequate contraception;
  • major surgical procedures, open biopsy, or significant traumatic injury, within 28 days prior to study treatment start;
  • current or recent treatment (within 28 days prior to randomization) with another investigational drug, or participation in another investigational study.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: December, 2004

Trial Registration Date: 06/24/2005

Date Last Updated: 07/15/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Long Beach, CA 90802
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: July 21, 2008 at 2:18:54 PM


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