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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00642824 |
Purpose
This single arm genetic substudy of MO19390 will test the hypothesis that there is a positive relationship between mRNA BRCAI levels and the response to different chemotherapy combinations plus Avastin. A subset of patients participating in MO19390, and receiving Avastin 15mg/kg iv on day 1 and subsequently once every 3 weeks, will undergo BRCAI mRNA expression determination. Depending on the BRCAI mRNA level (low, medium or high) they will receive a different chemotherapy regimen in combination with Avastin: a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 100-500 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Drug: bevacizumab [Avastin] Drug: Standard chemotherapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Local Substudy Associated to the International Study MO19390 to Determine the BRCA1 Gene mRNA Expression as a Predictive Marker of Response to Chemotherapy |
| Estimated Enrollment: | 40 |
| Estimated Study Completion Date: | June 2008 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: bevacizumab [Avastin]
15mg/kg iv or 7.5mg/kg on day 1, and subsequently once every 3 weeks
Drug: Standard chemotherapy
As prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Spain | |
| Alcorcon, Spain, 28922 | |
| Alcoy, Spain, 3804 | |
| Alicante, Spain, 03010 | |
| Badalona, Spain, 08915 | |
| Barakaldo, Spain, 48903 | |
| Burgos, Spain, 09005 | |
| Elche, Spain, 03202 | |
| Girona, Spain, 17007 | |
| Huesca, Spain, 22004 | |
| La Laguna, Spain, 38320 | |
| Las Palmas de Gran Canaria, Spain, 35016 | |
| Zaragoza, Spain, 50009 | |
| Madrid, Spain, 28002 | |
| Madrid, Spain, 28040 | |
| Madrid, Spain, 28046 | |
| Murcia, Spain, 30008 | |
| Palma de Mallorca, Spain, 07014 | |
| Pamplona, Spain, 31008 | |
| Salamanca, Spain, 37007 | |
| Valencia, Spain, 46009 | |
| Valencia, Spain, 41014 | |
| Lugo, Spain, 27004 | |
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Hoffmann-La Roche ( Disclosures Group ) |
| Study ID Numbers: | ML21150 |
| Study First Received: | March 19, 2008 |
| Last Updated: | February 15, 2010 |
| ClinicalTrials.gov Identifier: | NCT00642824 History of Changes |
| Health Authority: | Spain: Ministry of Health |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Physiological Effects of Drugs Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Growth Inhibitors Angiogenesis Modulating Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
