Sequential and Concomitant Chemoradiotherapy With Gemcitabine-Based Chemotherapy for Inoperable Stage IIIa and IIIb Non-Small Cell Lung Cancer: A Phase I/IIa Study
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of
gemcitabine and paclitaxel in combination with radiotherapy in patients with locally
advanced stage IIIA or IIIB non-small cell lung cancer. II. Assess response rate, duration
of response, disease free survival and failure in this patient population on this regimen.
III. Determine the pharmacokinetics of gemcitabine and paclitaxel during the
OUTLINE: This is a dose escalation study of gemcitabine. Induction phase: Patients receive
gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1.
Treatment repeats every 3 weeks for 2 courses. Chemoradiotherapy phase: Patients receive
paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes beginning 2 hours into
paclitaxel infusion on day 1 of weeks 6, 9, and 12. Patients undergo conventional chest
radiotherapy on Monday though Friday for weeks 6-11. Cohorts of 3-5 patients receive
escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the dose at which at least 2 of 5 patients experience dose limiting
PROJECTED ACCRUAL: A minimum of 17 patients will be accrued for this study.
Primary Purpose: Treatment
Francisco Robert, MD, FACP
University of Alabama at Birmingham
United States: Federal Government
|University of Alabama Comprehensive Cancer Center||Birmingham, Alabama 35294|