Feasibility of Dose Titrating Paricalcitol (Zemplar) in Women Receiving Taxanes or Ixabepilone for Metastatic Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
Feasibility of Dose Titrating Paricalcitol (Zemplar) in Women Receiving Taxanes or Ixabepilone for Metastatic Breast Cancer
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Inclusion Criteria
Inclusion Criteria
- Histologically confirmed invasive breast cancer
- Metastatic or recurrent disease
- Patients with bone metastasis only are eligible and evaluable for time to
progression
- 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
- History of allergy to calcitriol, paricalcitol, or other Vitamin D compounds
- History of drug or alcohol abuse within the past 6 months
- History of other malignancy except inactive nonmelanoma skin cancer, adequately
treated stage I or II cancer from which the patient is currently in complete
remission, or other cancer if the patient has been disease-free for 5 or more years
- Serious medical illness that would limit survival to < 3 months
- Active, uncontrolled bacterial, viral or fungal infection
- Poorly controlled diabetes
- Concurrent supplemental calcium
- Concurrent digitalis compounds
- Concurrent chemotherapy
- Concurrent biologic therapy, including trastuzumab and bevacizumab
- Concurrent hormonal agents for breast cancer except luteinizing hormone-releasing
hormone agonists
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical feasibility of therapy administration
Outcome Description:
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
Outcome Time Frame:
Baseline to 8 weeks
Safety Issue:
No
Principal Investigator
Julia A. Lawrence
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Institutional Review Board
Study ID:
CDR0000583652
NCT ID:
NCT00637897
Start Date:
March 2008
Completion Date:
November 2013
Related Keywords:
- Breast Cancer
- recurrent breast cancer
- stage IV breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
