Prostate CancerPhase 2NCT00182741
Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer
A Phase 2 study testing calcitriol, mitoxantrone hydrochloride and prednisone in people with Prostate Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Calcitriol may cause prostate cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as mitoxantrone and prednisone, 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 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- calcitriol, mitoxantrone hydrochloride and prednisone
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Aug 2006
- Phase
- Phase 2
- 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 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer
- Androgen-independent disease, defined as disease progression while on standard hormonal management, including antiandrogen withdrawal
- Patients must continue primary hormonal therapy during study treatment
- Regional or distant metastases
- Prostate-specific antigen > 5 ng/mL
- No brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 to 100
Performance status
- ECOG 0-3
Life expectancy
- Not specified
Hematopoietic
- Adequate hematologic function
Hepatic
- Adequate hepatic function
Renal
- Adequate renal function
- No calcium-salt kidney stones within the past 5 years
- No hypercalcemia
Cardiovascular
- Adequate cardiac function
- No significant cardiac disease
- No atrial fibrillation
Other
- Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment
- No other serious medical illness
- No other active malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 28 days since prior biologic therapy
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- No prior strontium chloride Sr 89
- More than 28 days since prior radiotherapy
- More than 56 days since prior samarium Sm 153 lexidronam pentasodium
Surgery
- Prior prostatectomy and/or orchiectomy allowed
Other
- More than 28 days since prior investigational therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239-3098
About this study
Official title: Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)
RATIONALE: Calcitriol may cause prostate cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as mitoxantrone and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well giving calcitriol together with mitoxantrone and prednisone works in treating patients with metastatic prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the prostate-specific antigen (PSA) response rate, defined as the fraction of patients with 50% reduction in PSA level over 3 weeks' time, in patients with androgen-independent metastatic prostate cancer treated with high-dose pulse calcitriol, mitoxantrone, and prednisone.
Secondary
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral high dose pulse calcitriol on day 1, mitoxantrone IV on day 2, and oral prednisone on days 1-21. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- calcitriol, mitoxantrone hydrochloride, prednisone
- Keywords
- recurrent prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcitriolDietary supplement
mitoxantrone hydrochlorideDrug
prednisoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days
Secondary outcomes (13)
Toxicity as measured by Common Toxicity Criteria v3.0
Frozen plasma and serum samples for correlative biomarker analysis collected every 21 days
Confirmed PSA reduction > 75% measured every 21 days
PSA normalization (< 4 ng/mL) measured every 21 days
Response to measurable disease as measured by RECIST criteria every 9 weeks
Analgesic response as measured by McGill-Melzack Pain Questionnaire every 21 days
Analgesic medication use decreased by ≥ 50% without an increase in pain for 2 consecutive evaluations at least 3 weeks apart
Palliative response as measured by McGill-Melzack Pain Questionnaire every 21 days
Quality of life as measured by EORTC core questionnaire Quality of Life-C30 every 21 days
Time to palliative-progression as measured by McGill-Melzack Pain Questionnaire every 21 days
Time to PSA progression measured every 21 days
Time to progression in measurable or evaluable disease as measured by whole body scan and/or CT or MRI scan every 9-12 weeks
Time to death assessed every 6 months after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Christopher Ryan, OHSU Knight Cancer Institute
- Investigators
- Christopher W. Ryan, MD, Study chair, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182741
- Sponsor's protocol ID
- CDR0000441172
- Other IDs
- OHSU-8451, OHSU-VA-IRB-9451
- Status last verified
- May 2017
- First submitted
- 15 Sep 2005
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan JS, Beer TM, Quinn DI, Pinski JK, Garzotto M, Sokoloff M, Dehaze DR, Ryan CW. A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer. BJU Int. 2008 Dec;102(11):1601-6. doi: 10.1111/j.1464-410X.2008.08017.x. Epub 2008 Sep 8.
PubMed 18782306
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)
- ClinicalTrials.gov ID
- NCT00182741
- Acronym / sponsor ID
- CDR0000441172
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer, stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 16 Sep 2005 (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: Calcitriol may cause prostate cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as mitoxantrone and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well giving calcitriol together with mitoxantrone and prednisone works in treating patients with metastatic prostate cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the prostate-specific antigen (PSA) response rate, defined as the fraction of patients with 50% reduction in PSA level over 3 weeks' time, in patients with androgen-independent metastatic prostate cancer treated with high-dose pulse calcitriol, mitoxantrone, and prednisone.
Secondary
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral high dose pulse calcitriol on day 1, mitoxantrone IV on day 2, and oral prednisone on days 1-21. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| calcitriol | Dietary supplement | – |
| mitoxantrone hydrochloride | Drug | – |
| prednisone | Drug | – |
Primary outcome
Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days
13 secondary outcomes
Toxicity as measured by Common Toxicity Criteria v3.0
Frozen plasma and serum samples for correlative biomarker analysis collected every 21 days
Confirmed PSA reduction > 75% measured every 21 days
PSA normalization (< 4 ng/mL) measured every 21 days
Response to measurable disease as measured by RECIST criteria every 9 weeks
Analgesic response as measured by McGill-Melzack Pain Questionnaire every 21 days
Analgesic medication use decreased by ≥ 50% without an increase in pain for 2 consecutive evaluations at least 3 weeks apart
Palliative response as measured by McGill-Melzack Pain Questionnaire every 21 days
Quality of life as measured by EORTC core questionnaire Quality of Life-C30 every 21 days
Time to palliative-progression as measured by McGill-Melzack Pain Questionnaire every 21 days
Time to PSA progression measured every 21 days
Time to progression in measurable or evaluable disease as measured by whole body scan and/or CT or MRI scan every 9-12 weeks
Time to death assessed every 6 months after completion of study treatment
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 3 May 2017.
- Results publication: PubMed 18782306Chan JS, Beer TM, Quinn DI, Pinski JK, Garzotto M, Sokoloff M, Dehaze DR, Ryan CW. A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer. BJU Int. 2008 Dec;102(11):1601-6. doi: 10.1111/j.1464-410X.2008.08017.x. Epub 2008 Sep 8.
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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.
Christopher W. Ryan, MD study chair
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing calcitriol, mitoxantrone hydrochloride and prednisone in people with Prostate Cancer, run by OHSU Knight Cancer Institute 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?
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 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182741, which also lists 1 linked publication.
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 3 May 2017.