Trial Information

Summary: A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.

Status: No longer recruiting

Protocol Number: MO19390

Sponsor: Hoffmann-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: Open label study of Avastin in combination with platinum-containing chemotherapy as 1st line treatment in patients with stage IIIb/IV non-squamous NSCLC

Brief Summary: This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals. Target sample size is 2000.

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: Non-Small Cell Lung Cancer

Intervention Type: Drug

Intervention Name: bevacizumab [Avastin]

Primary Outcome: 1. AEs, laboratory parameters. Time frame: Throughout study

Key Secondary Outcomes: 1. Duration of survival; time to disease progression. Time frame: Event driven

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
  • ECOG PS status 0-2;
  • life expectancy >= 12weeks;
  • adequate renal, liver and hematological function.

Exclusion Criteria:

  • mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
  • hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;
  • evidence of tumor invading major blood vessels on imaging;
  • evidence of CNS metastases, even if previously treated.
  • major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
  • prior chemotherapy for stage IIIb/IV disease.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: August, 2006

Trial Registration Date: 08/16/2006

Date Last Updated: 09/19/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Córdoba, Argentina, 5016
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: October 6, 2008 at 2:40:08 PM


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