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A Phase II Study of Erlotinib and Chemotherapy for Operable Stage IB-IIIA Non-Small Cell Lung Cancer Patients Who Are Nonsmokers or Light Smokers
[Protocol 07-103]
- Full Title :
- A PHASE II STUDY OF ERLOTINIB AND CHEMOTHERAPY FOR PATIENTS WITH STAGE IB-IIIA NSCLC WITH EGFR MUTATIONS (ECON)
- Purpose :
Docetaxel and cisplatin are traditional chemotherapy drugs that have been shown to help some patients with non-small cell lung cancer (NSCLC). Erlotinib is a newer drug which has benefited some patients with NSCLC. Many different types of cancer cells, including some types of lung cancer, have a protein on their surfaces called the epidermal growth factor receptor (EGFR). Erlotinib works by blocking this receptor and depriving the cancer cells of this message to grow and multiply.
The purpose of this study is to evaluate the safety and effectiveness of combining erlotinib and traditional chemotherapy drugs (pemetrexed and cisplatin) in previously untreated patients with operable stage IB-IIIA NSCLC who never smoked cigarettes or who smoked very little. A secondary purpose is to evaluate giving erlotinib to patients after surgery for two years. Researchers will also be looking for changes in the EGFR and KRAS genes from patients¿ tumors after they have been removed. KRAS is a gene that has been associated with resistance to erlotinib.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a diagnosis of previously untreated stage IB-IIIA NSCLC that can be surgically removed.
- Patients must have a history of smoking of 15 pack-years or less.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. Naiyer Rizvi at 212-639-3204.
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