Study Posting (4519) -- Trial #98979, Non-Small Cell Lung Cancer, Bahia Blanca, Argentina

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Trial Information

Summary: A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Status: No longer recruiting

Protocol Number: BO17704

Sponsor: Hoffmann-La Roche Ltd/Inc/AG/Roche Global Development

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of the effect of Avastin plus cisplatin and gemcitabine or placebo plus cisplatin and gemcitabine on progression-free survival in treatment-naīve patients with advanced or recurrent non-squamous NSCLC

Brief Summary: This study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous NSCLC who have not received prior chemotherapy. The anticipated time of study treatment is 1-2 years, and the target sample size is 500+ individuals. Target sample size is 1050.

Study Phase: III

Study Design / Study Details:

Purpose: Treatment
Allocation: Randomized
Masking: Open Label
Control: Placebo
Assignment: Parallel
Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Non-Small Cell Lung Cancer

Intervention Type: Drug

Intervention Name: bevacizumab[Avastin]

Primary Outcome: 1. Progression-free survival

Key Secondary Outcomes: 1. Efficacy: Duration of overall survival, time to treatment failure,, response rate, and duration of response. Safety: Adverse events, laboratory tests, serious adverse events, and coagulation parameters

Inclusion Criteria:

adult patients, >=18 years of age;
documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;
adequate liver and kidney function;
women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment.

Exclusion Criteria:

prior chemotherapy or treatment with another systemic cancer therapy;
surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment;
brain metastasis or spinal cord compression;
fertile men, and women of childbearing potential, not using adequate contraception;
treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: February, 2005

Trial Registration Date: 06/24/2005

Date Last Updated: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Bahia Blanca, Argentina, B8000ILD
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: June 30, 2008 at 3:02:38 PM

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