A Phase I Clinical Trial of Oral Calcitriol With Fixed Dose of Cisplatin and Gemcitabine in Patients With Advanced Solid Tumors
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of oral calcitriol when
combined with a standard dose of gemcitabine and cisplatin in a 28-day cycle. SECONDARY
OBJECTIVES: I. Describe the toxicity of this combination using CTCAE version 4.0. II. Study
the pharmacokinetics of calcitrio1 at the MTD in an expanded cohort of 6 patients. III.
Describe the clinical activity associated with this regimen in this advanced solid tumor
population. OUTLINE: Patients receive oral calcitriol on days 1, 2, 8, 9, 15 and 16;
cisplatin IV over 2 hours on day 2; and gemcitabine hydrochloride IV over 30 minutes on days
2, 9, 16. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity. After completion of study treatment, patients are followed at 30 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of oral calcitriol when combined with a standard dose of gemcitabine and cisplatin
Grace K Dy, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|