Phase II Trial of Weekly Docetaxel (Taxotere®) and Monthly Cisplatin Chemotherapy as Adjuvant Treatment for Patients With Completely Resected Non-Small Cell Lung Cancer
- Compare the efficacy and safety of a new dosing schedule and dosing level of docetaxel
and cisplatin with the chemotherapy regimens used in the International Adjuvant Lung
Cancer Trial (IALT) in patients with completely resected stage IA-IIIB non-small cell
- Explore the relationship of time to recurrence, disease-free survival, and overall
survival of these patients with levels of circulating DNA and proteomic analysis of
OUTLINE: This is an open-label study.
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 8
hours on day 15. Treatment repeats every 28 days for up to 4 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Total cisplatin dose
Charles M. Rudin, MD, PhD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|