Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)
The purpose of this study is to try to improve the odds that your cancer may be cured. Pemetrexed and cisplatin are traditional chemotherapy drugs that have been shown to help some patients with non-small cell lung cancer. Many different types of cancer cells, including your type of lung cancer, have a protein on their surface called the epidermal growth factor receptor (EGFR). Stimulation of these receptors can result in growth of cancer cells and progression of cancer. In addition, your cancer has an EGFR mutation (a specific abnormality in the genetic code for EGFR). Erlotinib (TarcevaTM) is a newer drug which has shown benefit for patients with lung cancers that contain an EGFR mutation. Erlotinib works by blocking this receptor and depriving the cancer cells of this message to grow and multiply. In this research study, we plan to combine erlotinib with traditional chemotherapy drugs to see if the combination works better than chemotherapy alone.
The main purpose of this research is to find out the good and bad effects that the combination of these 3 drugs (pemetrexed, cisplatin and erlotinib) has when given to patients with early stage non-small cell lung cancer before surgery. A secondary purpose is to find out the good and bad effects that occur when erlotinib is given to patients after surgery for 2 years.
|Non Small Cell Lung Cancer Lung Cancer||Drug: pemetrexed, cisplatin and erlotinib before surgery then erlotinib is given to patients after surgery for 2 years||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)|
- To Determine the Pathologic Complete Response Rate for Patients With Stage IB-IIIA NSCLC With Tumors That Harbor an EGFR Mutation Treated With Neoadjuvant Chemotherapy + Erlotinib [ Time Frame: Patients will undergo a CT scan of chest every 3 months for year 1 and every 4 months for year 2. In years 3 and 4, a chest CT or chest x-ray every 6 months. ]
- To Determine the Response Rate After 21 Days of Single Agent Erlotinib for Stage IB-IIIA NSCLC With a Known EGFR Mutation. [ Time Frame: calculate the response rate after 21 days of single agent erlotinib ]
- To Determine the Response Rate, 3-year Overall Survival and Median Survival of Patients With Stage IB-IIIA NSCLC With a Known EGFR Mutation Receiving Neoadjuvant Chemotherapy and Erlotinib (and Adjuvant Erlotinib). [ Time Frame: 3 years ]
|Study Start Date:||November 2007|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Erlotinib and chemotherapy for operable stage IB-IIIA NSCLC patients with less than or equal to 15 pack year smoking history
Drug: pemetrexed, cisplatin and erlotinib before surgery then erlotinib is given to patients after surgery for 2 years
One tablet daily of erlotinib pills (150 mg daily) for the first 21 days on this study and then a CT scan will be performed. After the CT scan you will start treatment with intravenous pemetrexed and cisplatin (pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 every 3 weeks for 4 cycles treatment) on the first day of each cycle of treatment. The duration of each cycle is 21 days. You will receive treatment for 4 cycles. You will be asked to stop taking the erlotinib at least 2 days before surgery. After surgery, you will be asked to take adjuvant erlotinib 150 mg po daily x 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577707
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Naiyer Rizvi, MD||Memorial Sloan Kettering Cancer Center|