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| Sponsored by: |
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: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Study Start Date: | May 2007 |
| 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 | |
| ALCOY, Spain, 3804 | |
| VALENCIA, Spain, 46009 | |
| ELCHE, Spain, 03202 | |
| MURCIA, Spain, 30008 | |
| MADRID, Spain, 28040 | |
| MADRID, Spain, 28046 | |
| BARAKALDO, Spain, 48903 | |
| BURGOS, Spain, 09005 | |
| ZARAGOZA, Spain, 50009 | |
| HUESCA, Spain, 22004 | |
| PAMPLONA, Spain, 31008 | |
| VALENCIA, Spain, 41014 | |
| PALMA DE MALLORCA, Spain, 07014 | |
| BADALONA, Spain, 08915 | |
| LA LAGUNA, Spain, 38320 | |
| LUGO, Spain, 27004 | |
| ALICANTE, Spain, 03010 | |
| LAS PALMAS DE GRAN CANARIA, Spain, 35016 | |
| MADRID, Spain, 28002 | |
| SALAMANCA, Spain, 37007 | |
| Alcorcon, Spain, 28922 | |
| GIRONA, Spain, 17007 | |
| Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
More Information
| Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
| Study ID Numbers: | ML21150 |
| Study First Received: | March 19, 2008 |
| Last Updated: | June 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00642824 History of Changes |
| Health Authority: | Spain: Ministry of Health |
|
Thoracic Neoplasms Bevacizumab Angiogenesis Inhibitors Recurrence Carcinoma Docetaxel Vinorelbine Cisplatin |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
|
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 |
