Trial Information

Summary: A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy

Status: No longer recruiting

Protocol Number: BO17705

Sponsor: F Hoffman-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: A randomised, double-blind study to evaluate the efficacy and safety of Avastin plus Roferon compared with placebo plus Roferon on overall survival and tumor assessment in nephrectomised patients with metastatic clear cell renal cell carcinoma

Brief Summary: This study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in patients with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is 500+ individuals. Target sample size is 638.

Study Phase: III

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Renal Cell Cancer

Intervention Type: Drug

Intervention Name: bevacizumab[Avastin]

Primary Outcome: 1. Overall survival.

Key Secondary Outcomes: 1. Efficacy: Progression-free survival, time to disease progression, time to treatment failure, objective response rates. Safety: Hematology, serum chemistry, urinalysis, and adverse events.

Inclusion Criteria:

  • adult patients;
  • >=18 years of age;
  • metastatic renal cell cancer (clear cell type);
  • nephrectomy;
  • absence of proteinuria.

Exclusion Criteria:

  • prior systemic treatment for metastatic renal cell cancer;
  • major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start;
  • presence of brain metastases;
  • 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

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:
Toulouse, France, 31059
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 21, 2008 at 2:35:50 PM


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