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A Genetic Substudy Associated With the Avastin (Bevacizumab) Study MO19390 in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.

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ClinicalTrials.gov Identifier: NCT00642824
Recruitment Status : Terminated (Terminated due to low enrollment. No statistical analyses were performed.)
First Posted : March 25, 2008
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: Standard chemotherapy Drug: bevacizumab [Avastin] Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: 1 Drug: Standard chemotherapy
As prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel.

Drug: bevacizumab [Avastin]
15mg/kg iv or 7.5mg/kg on day 1, and subsequently once every 3 weeks




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Event driven ]

Secondary Outcome Measures :
  1. Overall survival; response rates [ Time Frame: Event driven ]
  2. Adverse events [ Time Frame: Throughout study ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • participating in, and meeting all inclusion/exclusion criteria of, MO19390.

Exclusion Criteria:

  • not meeting the inclusion/exclusion criteria of MO19390.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642824


Locations
Spain
Alcorcon, Spain, 28922
Alcoy, Spain, 03804
Alicante, Spain, 03010
Badalona, Spain, 08915
Barakaldo, Spain, 48903
Burgos, Spain, 09005
Elche, Spain, 03203
Girona, Spain, 17007
Huesca, Spain, 22004
La Laguna, Spain, 38320
Las Palmas de Gran Canaria, Spain, 35016
Lugo, Spain, 27004
Madrid, Spain, 28006
Madrid, Spain, 28040
Madrid, Spain, 28046
Murcia, Spain, 30008
Palma de Mallorca, Spain, 07014
Pamplona, Spain, 31008
Salamanca, Spain, 37007
Valencia, Spain, 41014
Valencia, Spain, 46009
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00642824     History of Changes
Other Study ID Numbers: ML21150
First Posted: March 25, 2008    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents