Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer

NCT00637897 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: CDR0000583652P30CA012197CCCWFU-74307
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

  Baseline to 8 weeks

• Measurement of effect of combination of paricalcitol and a taxane or ixabepilone on parathyroid hormone levels failure

  Baseline to 8 weeks

Study Arms (1)

Paricalcitol (Zemplar)

EXPERIMENTAL

Paricalcitol (Zemplar)

Drug: docetaxel; Drug: ixabepilone; Drug: paclitaxel; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Drug: paricalcitol

Interventions

docetaxel DRUG

Paricalcitol (Zemplar)

ixabepilone DRUG

Paricalcitol (Zemplar)

paclitaxel DRUG

Paricalcitol (Zemplar)

paclitaxel albumin-stabilized nanoparticle formulation DRUG

Paricalcitol (Zemplar)

paricalcitol DRUG

Paricalcitol (Zemplar)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; ixabepilone; Paclitaxel; Taxes; paricalcitol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Study Officials

• Julia A. Lawrence

  Wake Forest University Health Sciences

  STUDY CHAIR

• Susan A. Melin, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 18, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: March 1, 2013
• Last Updated: May 30, 2017

Record last verified: 2015-10

Locations

US (1)