Adult Solid Neoplasm Clinical Trial
Official title:
A Phase I Clinical Trial of Oral Calcitriol With Fixed Dose of Cisplatin and Gemcitabine in Patients With Advanced Solid Tumors
This phase I trial studies the side effects and best dose of calcitriol when given with cisplatin and gemcitabine hydrochloride in treating patients with advanced solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Calcitriol may stop the growth of tumor cells by blocking blood flow to the tumor. Calcitriol may also help cisplatin and gemcitabine hydrochloride kill more tumor cells by making them more sensitive to the drug.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of oral calcitriol when combined with a standard
dose of gemcitabine (gemcitabine hydrochloride) and cisplatin in a 28-day cycle.
SECONDARY OBJECTIVES:
I. Describe the toxicity of this combination using Common Terminology Criteria for Adverse
Events (CTCAE) version 4.0.
II. Study the pharmacokinetics of calcitriol at the maximum tolerated dose (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 calcitriol orally (PO) on days 1, 2, 8, 9, 15 and 16; cisplatin
intravenously (IV) over 2 hours on day 2; and gemcitabine hydrochloride IV over 30 minutes
on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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