Trial Information

Summary: A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer

Status: Completed

Protocol Number: BO17706

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of the effect of Avastin plus gemcitabine and erlotinib compared with placebo plus gemcitabine and erlotinib on overall survival in patients with metastatic pancreatic cancer

Brief Summary: This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals. Target sample size is 600.

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: Pancreatic Cancer

Intervention Type: Drug

Intervention Name: bevacizumab[Avastin]

Primary Outcome: 1. Overall survival

Key Secondary Outcomes: 1. Efficacy: Tumor assessment, progression-free survival and clinical benefit response rate. Safety: Hematology, coagulation, blood chemistry, and urinalysis.

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • metastatic pancreatic cancer (adenocarcinoma);
  • good liver, kidney, and bone marrow function.

Exclusion Criteria:

  • previous systemic treatment for metastatic pancreatic cancer;
  • pregnant or lactating females;
  • fertile men, or women of childbearing potential, not using adequate contraception;
  • major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start;
  • current or recent treatment (within 30 days prior to starting study treatment) 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: July, 2005

Trial Registration Date: 06/24/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Heidelberg, Australia, 3084
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: August 20, 2008 at 2:13:52 PM


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