Molecular and Genetic Changes in Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Cisplatin and Alimta - Phase II Study
- Determine the pathologic complete response in patients with stage IB-IIIB non-small
cell lung cancer treated with neoadjuvant chemotherapy comprising pemetrexed disodium
and cisplatin followed by surgery and adjuvant pemetrexed disodium and cisplatin.
- Determine the adverse events of this regimen in these patients.
- Determine the overall and disease-free survival of patients treated with this regimen.
- Correlate response with the presence or absence of ERCC1 and DHFR, thymidylate
synthase, DPD, and GARFT in patients treated with this regimen.
- Correlate the fragile site on chromosome 12 within the SMRT gene with metastasis after
definitive treatment with this regimen in these patients.
- Neoadjuvant chemotherapy: Patients receive pemetrexed disodium IV over 10 minutes
followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21
days for 3 courses. Patients are then evaluated for disease resectability. Patients
with no evidence of disease progression proceed to thoracotomy within the next 28-48
- Thoracotomy: Patients found to have unresectable disease during thoracotomy receive
further treatment off study. Patients with resectable disease undergo complete surgical
resection of the tumor. Forty to eighty days later, patients proceed to adjuvant
- Adjuvant chemotherapy: Patients receive pemetrexed disodium and cisplatin as before for
Patients with progressive disease after completion of neoadjuvant chemotherapy are followed
every 6 months. All other patients are followed every 3 months for 2 years, every 6 months
for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study over 6.5 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologically complete response
Grace K. Dy, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|