Biweekly Gemcitabine and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer and Solid Tumors: A Phase I/IIa Study
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicities of biweekly
administration of gemcitabine and paclitaxel in patients with advanced non-small cell lung
cancer (NSCLC) or other solid tumor. II. Determine the response rate, duration of response,
and disease free interval for this patient population after this therapy.
OUTLINE: This is a dose escalation study. Patients receive paclitaxel IV over 1 hour
followed 2 hours later by gemcitabine IV over 30 minutes on days 1, 15, and 29. Treatment
repeats every 6 weeks for a maximum of 8 courses. Cohorts of 3-5 patients receive escalating
doses of paclitaxel and gemcitabine until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose
limiting toxicity. Once the MTD is reached, an additional 14 patients (chemotherapy naive)
with advanced NSCLC are treated at the recommended phase II dose. Patients are followed
every 8 weeks for 6 months.
PROJECTED ACCRUAL: A minimum of 3 patients will be accrued for the phase I portion and a
total of 14 patients will be accrued for the phase II portion of 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|