Phase I Study of Continuous Infusion Gemcitabine
- Determine the maximum tolerated dose of continuous infusion gemcitabine in patients
with metastatic malignancies.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients on dose levels 1-5 receive gemcitabine IV continuously over 72 hours on week 1.
Patients on dose levels 6 and 7 receive gemcitabine IV continuously over 72 hours on weeks
1-3. Courses repeat every 2 weeks (for patients on dose levels 1-5) and every 4 weeks (for
patients on dose levels 6 and 7) in the absence of disease progression or unacceptable
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6
patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Primary Purpose: Treatment
Brian L. Samuels, MD
Lutheran General Hospital
United States: Federal Government
|Lutheran General Cancer Care Center||Park Ridge, Illinois 60068|