Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00637897
First received: March 17, 2008
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: docetaxel
Drug: ixabepilone
Drug: paclitaxel
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Drug: paricalcitol
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Dose Titrating Paricalcitol (Zemplar) in Women Receiving Taxanes or Ixabepilone for Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Clinical feasibility of therapy administration [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Dose of paricalcitol that maintains a normal calcium level when given in combination with a taxane or ixabepilone [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
  • Correlation of baseline levels of 25-hydroxycholecalciferol and parathyroid hormone with time to treatment failure [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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

  • Measurement of effect of combination of paricalcitol and a taxane or ixabepilone on parathyroid hormone levels failure [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    To determine if parathyroid hormone levels decline from baseline with the combination of paricalcitol and a taxane or ixabepilone


Enrollment: 24
Study Start Date: March 2008
Study Completion Date: March 2013
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637897

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Julia A. Lawrence Comprehensive Cancer Center of Wake Forest University
Principal Investigator: Susan A. Melin, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00637897     History of Changes
Obsolete Identifiers: NCT01055288
Other Study ID Numbers: CDR0000583652, P30CA012197, CCCWFU-74307
Study First Received: March 17, 2008
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
recurrent breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Ergocalciferols
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Bone Density Conservation Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014