Status:
COMPLETED
Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE1
Brief Summary
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,...
Detailed Description
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00637897
Start Date
March 1 2008
End Date
March 1 2013
Last Update
May 30 2017
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096