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:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00800202
First received: December 1, 2008
Last updated: May 23, 2013
Last verified: May 2013
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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:
Drug Information available for:
Paclitaxel
Carboplatin
Erlotinib hydrochloride
Erlotinib
Bevacizumab
U.S. FDA Resources
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, 38434 | |
| 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: | May 23, 2013 |
| 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 May 23, 2013