An Open Label, Dose Escalation Study of Paricalcitol (Zemplar™) [19-NOR-1 ALPHA, 25-(OH) D] in Combination With Gemcitabine [2', 2' -Difluorodeoxycytidine] in Patients With Advanced Malignancies
- Determine the maximum tolerated dose (MTD) of paricalcitol when given with gemcitabine
in patients with advanced malignancy.
- Determine safety and toxicity of this regimen in these patients.
- Determine the pharmacokinetics of these regimens in these patients.
- Determine the clinical outcome (overall survival and best overall response) of patients
treated with this regimen.
OUTLINE: This is a dose-escalation, open-label study.
Patients receive gemcitabine IV over 80 minutes on days 1, 8, and 15 and paricalcitol IV
over 15 minutes on days 7 and 14 in course 1. Beginning in course 2, patients receive
paricalcitol IV over 15 minutes on days 1, 8, and 15 and gemcitabine IV over 80 minutes on
days 2, 9, and 16. Courses repeat every 4 weeks in the absence of disease progression or
Cohorts of 3-6 patients receive escalating doses of paricalcitol until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the
After completion of study treatment, patients are followed for survival.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) of i. v. pancalcitol given weekly, in combination with fixed dose rate infusion of i. v.gemcitabine given weekly in patients with advanced malignancies.
Renuka Iyer, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|