Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: Female

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, 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Docetaxel; Ergocalciferols; Paclitaxel

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