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Sponsors and Collaborators: |
Fatebenefratelli and Ophthalmic Hospital Mario Negri Institute for Pharmacological Research Niguarda Hospital |
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Information provided by: | Fatebenefratelli and Ophthalmic Hospital |
ClinicalTrials.gov Identifier: | NCT00637910 |
The aim of this study is to assess whether clinical and biological features are able to predict efficacy of Tyrosine kinase inhibitors.
Condition | Intervention | Phase |
---|---|---|
Non Small Cell Lung Cancer (NSCLC) |
Drug: Erlotinib Drug: Docetaxel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Optimization of Erlotinib for the Treatment of Patients With Advanced Non Small Cell Lung Cancer: an Italian Randomized Trial |
Estimated Enrollment: | 1500 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Erlotinib Arm: Experimental |
Drug: Erlotinib
Erlotinib 150 mg/day per os until disease progression or unacceptable toxicity develops
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Docetaxel Arm: Active Comparator |
Drug: Docetaxel
Docetaxel 75 mg/mq on day 1, every 21 days (3-weekly schedule) or Docetaxel 35 mg/mq 0n day 1,8 and 15 every 28 days (weekly schedule). _Until disease progression or unacceptable toxicity develops
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Erlotinib is registered in all patients affected with NSCLC in second and subsequent lines with a small benefit. Recent evidence suggest that it should be possible to select patients according with clinical and biological features. However, most of these proofs are drawn from case series or post hoc analyses and not from properly planned randomized clinical trials rendering their interpretation controversial. EGFR mutations, EGFR copy number and EGFR expression should positive select responders, while K-ras mutations should predict a negative outcome.
Moreover, recent studies showed that similar information might be drawn also on blood samples.
While it is possible to assume that in patients with EGFR mutations erlotinib improves Overall Survival (OS) and gives prolonged and high responses, the role of erlotinib in patients without EGFR mutations is controversial. On this assumption, the predictive value of K-ras mutations, EGFR protein expression and EGFR gene copy number in determining the effect of erlotinib as compared with chemotherapy will be assessed in patients without EGFR mutations. Aim of the study is to assess whether it is possible to optimize second-line treatment in NSCLC using biological and clinical markers.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marina C Garassino, MD | +39 0263632223 | marina.garassino@fbf.milano.it |
Contact: Aurora Rizzo, PharmD | +39 0263632223 | oncologia.ricerca@fbf.milano.it |
Principal Investigator: | Alberto Scanni, MD | Fatebenefratelli and Ophthalmic Hospital |
Responsible Party: | Fatebenefratelli and Ophthalmic Hospital ( Alberto Scanni ) |
Study ID Numbers: | FARM6F5JER, EudraCT Number 2007-004786-17 |
Study First Received: | March 12, 2008 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00637910 History of Changes |
Health Authority: | Italy: Ethics Committee; Italy: Ministry of Health; Italy: National Bioethics Committee; Italy: National Institute of Health; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Italy: The Italian Medicines Agency |
Advanced NSCLC EGFR EGFR copy number Kras mutations |
EGRF mutations Docetaxel Erlotinib Polymorphisms |
Erlotinib Docetaxel Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Protein Kinase Inhibitors Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Erlotinib Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Docetaxel Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |