Phase II Trial of Gemcitabine/Paraplatin® (Carboplatin) Followed by Taxol® (Paclitaxel) in Patients With Performance Status = 2,3 or Other Significant Co-Morbidity (HIV Infection or s/p Organ Transplantation) in Advanced Non-Small Cell Lung Cancer
- Determine the efficacy and tolerability of gemcitabine hydrochloride and carboplatin
followed by paclitaxel in patients with stage IIIB-IV non-small cell lung cancer in
regard to response rate, median survival, and one year survival.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is multicenter study.
- Part 1: Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine
hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2
courses. In week 7, all patients proceed to part 2 regardless of disease response.
- Part 2: Patients receive paclitaxel IV over 1-3 hours once weekly for 6 weeks.
Treatment repeats every 8 weeks in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Julie Brahmer, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|