| ID | Type | Description | Link |
|---|---|---|---|
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| CCCWFU-74307 | Other Identifier | Comprehensive Cancer Center of WFUHS |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol (Zemplar) | Experimental | Paricalcitol (Zemplar) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug |
| ||
| ixabepilone |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dose of paricalcitol that maintains a normal calcium level when given in combination with a taxane or ixabepilone | Baseline to 8 weeks | |
| Correlation of baseline levels of 25-hydroxycholecalciferol and parathyroid hormone with time to treatment failure | 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 |
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Inclusion Criteria
Histologically confirmed invasive breast cancer
Candidate for taxane or ixabepilone therapy
At least one lesion that can be measured in at least one diameter ≥ 2 cm by CT scan
No symptomatic brain metastases or other symptomatic CNS metastases
ECOG performance status 0 or 1
Life expectancy > 3 months
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 g/dL
Serum creatinine ≤ 2.0 mg/dL
Total bilirubin ≤ 2.0 g/dL
Albumin corrected serum calcium < 10.5 mg/dL
Fertile patients must use effective contraception during and for at least 1 year after study participation
At least 2 weeks since prior chemotherapy or radiation therapy
Prior and concurrent taxane or ixabepilone therapy allowed
Concurrent oral multivitamins allowed (i.e., Centrum or One a Day)
Concurrent bisphosphonates allowed
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Julia A. Lawrence | Wake Forest University Health Sciences | Study Chair |
| Susan A. Melin, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| C430592 | ixabepilone |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| C084656 | paricalcitol |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| paclitaxel | Drug |
|
| paclitaxel albumin-stabilized nanoparticle formulation | Drug |
|
| paricalcitol | Drug |
|
| Baseline to 8 weeks |
| Measurement of effect of combination of paricalcitol and a taxane or ixabepilone on parathyroid hormone levels failure | To determine if parathyroid hormone levels decline from baseline with the combination of paricalcitol and a taxane or ixabepilone | Baseline to 8 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |