A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00800202
First received: December 1, 2008
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

This study will assess the efficacy and safety of Avastin combined with first line paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patients with non-squamous non-small cell lung cancer with asymptomatic untreated brain metastasis. Two cohorts of patients will be studied; the first will receive Avastin 15mg/kg iv every 3 weeks combined with first line paclitaxel 200mg/m2 iv plus carboplatin AUC6 iv every 3 weeks for a maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks combined with second line Tarceva 150mg/kg po.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab [Avastin]
Drug: paclitaxel
Drug: carboplatin
Drug: erlotinib [Tarceva]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Assess the Effect of Avastin (Bevacizumab) Combined With First Line Paclitaxel-carboplatin or Second Line Tarceva (Erlotinib) on Progression-free Survival in Non-squamous Non-small Cell Lung Cancer Patients With Asymptomatic Untreated Brain Metastasis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: April 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
15mg/kg iv every 3 weeks
Drug: paclitaxel
200mg/m2 iv every 3 weeks for 6 cycles
Drug: carboplatin
AUC6 iv every 3 weeks for 6 cycles
Experimental: 2 Drug: bevacizumab [Avastin]
15mg/kg iv every 3 weeks
Drug: erlotinib [Tarceva]
150mg/day po

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • stage IV non-squamous non-small cell lung cancer;
  • asymptomatic, untreated brain metastasis;
  • ECOG performance status 0-1.

Exclusion Criteria:

  • previous treatment for brain metastasis;
  • history of migraine or epilepsy;
  • previous treatment with angiogenesis inhibitors;
  • for cohort 2, previous first line treatment with Avastin or Tarceva;
  • current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agent for therapeutic purposes.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800202

Locations
France
Bordeaux, France, 33076
Brest, France, 29200
Caen, France, 14076
Chartres, France, 28018
Creteil, France, 94010
GAP, France, 05007
Gleize, France, 69400
La Tronche, France, 38700
Lille, France, 59020
Lyon, France, 69317
Marseille, France, 13274
Marseille, France, 13273
Montpellier, France, 34295
Paris, France, 75674
Paris, France, 75475
Paris, France, 75230
Paris, France, 75970
Pierre Benite, France, 69495
Rennes, France, 35033
Saint Herblain, France, 44805
Strasbourg, France, 67065
Toulon, France, 83041
Toulouse, France, 31400
Vandoeuvre Les Nancy, France, 54511
Vandoeuvre-les-nancy, France, 54511
Villejuif, France, 94805
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00800202     History of Changes
Other Study ID Numbers: ML21823, 2008-006504-33
Study First Received: December 1, 2008
Last Updated: March 3, 2014
Health Authority: France:AFSSAPS

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Bevacizumab
Carboplatin
Paclitaxel
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014