Paricalcitol and Gemcitabine in Treating Patients With Advanced Cancer
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Registration Number
- NCT00217477
- Lead Sponsor
- Roswell Park Cancer Institute
- Brief Summary
RATIONALE: Paricalcitol may cause cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving paricalcitol together with gemcitabine may be an effective treatment for cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of paricalcitol when given together with gemcitabine in treating patients with advanced cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the maximum tolerated dose (MTD) of paricalcitol when given with gemcitabine in patients with advanced malignancy.
Secondary
* 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 unacceptable toxicity.
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 MTD.
After completion of study treatment, patients are followed for survival.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Paricalcitol IV in combination with Gemcitabine IV gemcitabine hydrochloride Patients receive gemcitabine hydrochloride 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 hydrochloride IV over 80 minutes on days 2, 9, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Paricalcitol IV in combination with Gemcitabine IV paricalcitol Patients receive gemcitabine hydrochloride 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 hydrochloride IV over 80 minutes on days 2, 9, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method 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. 4 weeks
- Secondary Outcome Measures
Name Time Method To assess toxicity. 8 week intervals To determine the effects of paricalcitol on the pharmacokinetics of gemcitabine. Days 1 & 8, cycle 1 To determine the effects of pariclcitol on cytidine deaminase in PBM Days 1 & 8, cycle 1 To determine the effects of paricalcitol on dFdCTP in PBM Days 1 & 8, cycle 1 To determine the pharmacokinetics of paricalcitol when given with gemcitabine Day 7, cycle 1 To describe clinical outcome for response and survival 8 week intervals
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States