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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 |
| MedlinePlus related topics: | Cancer Lung Cancer |
| ChemIDplus related topics: | Cisplatin Vinorelbine Vinorelbine tartrate Docetaxel Gemcitabine hydrochloride Gemcitabine Bevacizumab |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, 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.
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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 | |||||
| VALENCIA, Spain, 46009 | |||||
| MURCIA, Spain, 30008 | |||||
| MADRID, Spain, 28040 | |||||
| MADRID, Spain, 28046 | |||||
| BARAKALDO, Spain, 48903 | |||||
| ZARAGOZA, Spain, 50009 | |||||
| HUESCA, Spain, 22004 | |||||
| PAMPLONA, Spain, 31008 | |||||
| GIRONA, Spain, 17007 | |||||
| VALENCIA, Spain, 41014 | |||||
| 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 | |||||
| PALMA DE MALLORCA, Spain, 07014 | |||||
| Hoffmann-La Roche |
| 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 |
| First Received: | March 19, 2008 |
| Last Updated: | September 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00642824 |
| Health Authority: | Spain: Ministry of Health |
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