Breast CancerPhase 1NCT00637897
Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer
A Phase 1 study testing docetaxel, ixabepilone and paclitaxel in people with Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- docetaxel, ixabepilone and paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Mar 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Feasibility of Dose Titrating Paricalcitol (Zemplar) in Women Receiving Taxanes or Ixabepilone for Metastatic Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- docetaxel, ixabepilone, paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation, paricalcitol
- Keywords
- recurrent breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
ixabepiloneDrug
paclitaxelDrug
paclitaxel albumin-stabilized nanoparticle formulationDrug
paricalcitolDrug
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol (Zemplar) | Experimental | Paricalcitol (Zemplar) Receives: Drug: docetaxel; Drug: ixabepilone; Drug: paclitaxel; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Drug: paricalcitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline to 8 weeks
Correlation of baseline levels of 25-hydroxycholecalciferol and parathyroid hormone with time to treatment failure
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
Measured: Baseline to 8 weeks
Measurement of effect of combination of paricalcitol and a taxane or ixabepilone on parathyroid hormone levels failure
To determine if parathyroid hormone levels decline from baseline with the combination of paricalcitol and a taxane or ixabepilone
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionNov 2011
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Julia A. Lawrence, Study chair, Wake Forest University Health SciencesSusan A. Melin, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637897
- Sponsor's protocol ID
- CDR0000583652
- Other IDs
- P30CA012197, CCCWFU-74307
- Status last verified
- Oct 2015
- First submitted
- 17 Mar 2008
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Dose Titrating Paricalcitol (Zemplar) in Women Receiving Taxanes or Ixabepilone for Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00637897
- Acronym / sponsor ID
- CDR0000583652
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage IV breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paricalcitol (Zemplar) | Experimental | Drug: docetaxel, Drug: ixabepilone, Drug: paclitaxel, Drug: paclitaxel albumin-stabilized nanoparticle formulation, Drug: paricalcitolParicalcitol (Zemplar) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically confirmed invasive breast cancer
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel | Drug | Paricalcitol (Zemplar) |
| ixabepilone | Drug | Paricalcitol (Zemplar) |
| paclitaxel | Drug | Paricalcitol (Zemplar) |
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | Paricalcitol (Zemplar) |
| paricalcitol | Drug | Paricalcitol (Zemplar) |
Primary outcome
Clinical feasibility of therapy administration
Time frame: Baseline to 8 weeks
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
3 secondary outcomes
Dose of paricalcitol that maintains a normal calcium level when given in combination with a taxane or ixabepilone
Time frame: Baseline to 8 weeks
Correlation of baseline levels of 25-hydroxycholecalciferol and parathyroid hormone with time to treatment failure
Time frame: Baseline to 8 weeks
Measurement of effect of combination of paricalcitol and a taxane or ixabepilone on parathyroid hormone levels failure
Time frame: Baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia A. Lawrence study chair
Wake Forest University Health Sciences
Susan A. Melin, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing docetaxel, ixabepilone and paclitaxel in people with Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical feasibility of therapy administration (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.