Phase II Study of Concurrent Cisplatin/Pemetrexed and RT Followed by Docetaxel in Stage III NSCLC (Non Small Cell Lung Cancer)
- Assess 1-year survival of stage III non-small cell lung cancer (NSCLC) patients treated
with cisplatin, pemetrexed disodium, and concurrent thoracic radiotherapy followed by
consolidation therapy with docetaxel.
- Assess the progression-free survival and overall survival.
- Assess the toxicity of this regimen.
OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV
over 60 minute on day 1. Treatment repeats every 21 days for 3 courses in the absence of
unacceptable toxicity. Patients also receive concurrent thoracic radiotherapy in weeks 1-7.
Between 3-8 weeks after completion of chemoradiotherapy, patients with no progressive
disease receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21
days for 3 courses.
After completion of study therapy, patients are followed at 1 month and periodically
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
at 1 year
Shirish M. Gadgeel, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Veterans Affairs Medical Center - Detroit||Detroit, Michigan 48201-1932|