NCT01093092

Calcitriol, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors That Cannot Be Removed by Surgery

A Phase I Clinical Trial of Oral Calcitriol With Fixed Dose of Cisplatin and Gemcitabine in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adult Solid Neoplasm

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Calcitriol	Given PO
DRUG	Cisplatin	Given IV
DRUG	Gemcitabine Hydrochloride	Given IV
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-06-01
• Completion: 2015-11-01
• First posted: 2010-03-25
• Last updated: 2016-01-12

Locations

2 sites across 1 country: United States