Spots Global Cancer Trial Database for Paricalcitol and Gemcitabine in Treating Patients With Advanced Cancer

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Trial Identification

Brief Title: Paricalcitol and Gemcitabine in Treating Patients With Advanced Cancer

Official Title: 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

Study ID: NCT00217477

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

gemcitabine hydrochloride

paricalcitol

Study Description

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.