Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, docetaxel,, paclitaxel, and ixabepilone work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paricalcitol may help chemotherapy drugs to kill more tumor cells by making tumor cells more sensitive to the drugs.
PURPOSE: This clinical trial is studying the best dose and best way to give paricalcitol and to see how well it works when given together with chemotherapy in treating patients with metastatic breast cancer.
Drug: paclitaxel albumin-stabilized nanoparticle formulation
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Feasibility of Dose Titrating Paricalcitol (Zemplar) in Women Receiving Taxanes or Ixabepilone for Metastatic Breast Cancer|
- Clinical feasibility of therapy administration [ Time Frame: Baseline to 8 weeks ]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
- Dose of paricalcitol that maintains a normal calcium level when given in combination with a taxane or ixabepilone [ Time Frame: Baseline to 8 weeks ]
- Correlation of baseline levels of 25-hydroxycholecalciferol and parathyroid hormone with time to treatment failure [ Time Frame: Baseline to 8 weeks ]To determine if baseline levels of 25(OH)D and parathyroid hormone are associated with time to treatment failure in patients treated with the combination of paricalcitol and a taxane or ixabepilone
- Measurement of effect of combination of paricalcitol and a taxane or ixabepilone on parathyroid hormone levels failure [ Time Frame: Baseline to 8 weeks ]To determine if parathyroid hormone levels decline from baseline with the combination of paricalcitol and a taxane or ixabepilone
|Study Start Date:||March 2008|
|Study Completion Date:||March 2013|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: Paricalcitol (Zemplar)
|Drug: docetaxel Drug: ixabepilone Drug: paclitaxel Drug: paclitaxel albumin-stabilized nanoparticle formulation Drug: paricalcitol|
- 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 unacceptable toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637897
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Julia A. Lawrence||Wake Forest University Health Sciences|
|Principal Investigator:||Susan A. Melin, MD||Wake Forest University Health Sciences|