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A Phase I/II Study of Cetuximab and Erlotinib in Patients with Lung Adenocarcinoma Who Have Developed Resistance to Erlotinib Alone
[Protocol 08-055]
- Full Title :
- A PHASE I/II TRIAL OF CETUXIMAB IN PATIENTS WITH LUNG ADENOCARCINOMA RECEIVING ERLOTINIB THAT HAVE DEVELOPED "ACQUIRED RESISTANCE" TO ERLOTINIB
- Purpose :
The purpose of this study is to determine if cetuximab can shrink lung cancers that initially became smaller after taking erlotinib and then started to get bigger despite continuing treatment. Cetuximab is approved for treating head and neck cancers and advanced colon cancer; its use in lung cancer treatment is considered investigational.
The goal of the phase I portion of this study is to determine the highest dose of cetuximab that can be given together safely with erlotinib. This study will also give researchers an idea of how well cetuximab shrinks adenocarcinoma of the lung when it is used with erlotinib.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of adenocarcinoma of the lung that originally responded to and then continued to grow despite more than 3 months of treatment with erlotinib, or patients must have a documented mutation in EGFR exons 19 or 21.
- At least 14 days must have passed since prior radiation therapy, 28 days since any major surgery, and 30 days since systemic therapy and entry into the study.
- Patients may not have previously received cetuximab.
- Patients must be age 18 or older
For more information and to inquire about eligibility for this study, please contact Dr. Gregory Riely at 212-639-3042.
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