Feasibility of Dose Titrating Paricalcitol (Zemplar) in Women Receiving Taxanes or Ixabepilone for Metastatic Breast Cancer
- To determine the ability to administer 8 continuous weeks of therapy within the first 3
months of enrollment with paricalcitol when given together with taxane or ixabepilone
therapy in women with metastatic breast cancer.
- To estimate the proportion of patients who successfully complete 8 continuous weeks of
therapy as well as the proportion of patients who achieve a 'steady-state' dose.
- To determine a dose of paricalcitol that can be taken continuously that maintains a
normal calcium level when combined with a taxane or ixabepilone.
- To determine if baseline levels of 25-hydroxycholecalciferol and parathyroid hormone
(PTH) are associated with time to treatment failure in these patients.
- To determine if PTH levels decline from baseline in patients treated with paricalcitol
in combination with taxane or ixabepilone therapy.
OUTLINE: Beginning on day 1, patients receive oral paricalcitol. The dose of paricalcitol is
increased every 2 weeks until the serum calcium level is between 9 mg/dL and 11.4 mg/dL.
Once this level is reached, the patient continues at that dose for the duration of the
study. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation,
docetaxel, or paclitaxel once a week or once every 3 weeks or ixabepilone once every 3
weeks. Treatment continues for at least 12 weeks in the absence of disease progression or
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical feasibility of therapy administration
To test the clinical/logistical feasibility of using a titrated dose of the vitamin D analog (paracalcitol or Zemplar) in combination with a taxane or ixabepilone primarily by measuring the proportion of patients who successfully complete 8 continuous weeks of therapy as well as the proportion of patients who achieve a 'steady-state' dose
Baseline to 8 weeks
Julia A. Lawrence
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|