Prostate CancerPhase 2NCT00524589
Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
A Phase 2 study testing calcitriol, dexamethasone and protein expression analysis in people with Prostate Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug. Read more about this study
- Who is it for?
- Ages Up to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- calcitriol, dexamethasone and protein expression analysis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Sep 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 120 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- History of androgen-independent prostate cancer
- Evidence of rising PSA level (with or without new lesion by radiograph or physical examination), defined as follows:
- PSA level > 5 ng/mL and clearly rising on 2 measurements taken ≥ 2 weeks apart after androgen deprivation therapy (i.e., orchiectomy or luteinizing hormone-releasing hormone [LHRH] analogue) and antiandrogen withdrawal, if appropriate
- PSA rising before and on the first value taken at 4 or 6 weeks after antiandrogen cessation is considered disease progression
- Measurable or evaluable disease as defined by any of the following:
- Measurable or evaluable tumor masses by radiograph or physical examination
- Evaluable PSA
- Concurrent LHRH analogue or diethylstilbestrol (DES) for testicular androgen suppression required if no prior bilateral orchiectomy
- Patients receiving other monotherapy for testicular androgen suppression must switch to a LHRH analogue or DES ≥ 14 days prior to study entry
PATIENT CHARACTERISTICS:
- ECOG 0-2
- Life expectancy ≥ 12 weeks
- ANC ≥ 1,000/mm³
- Platelet count ≥ 75,000/mm³
- Hemoglobin > 8.9 g/dL (transfusion or erythropoietin support allowed)
- Serum creatinine ≤ 1.8 mg/dL
- AST ≤ 4 times upper limit of normal (ULN)
- Total bilirubin ≤ 2.0 mg/dL
- Serum corrected calcium < ULN
- No history of nephrolithiasis within the past 5 years
- No unstable, uncontrolled peptic ulcer disease, congestive heart failure, glaucoma, HIV, or diabetes
PRIOR CONCURRENT THERAPY:
- At least 28 days since prior androgen deprivation therapy (≥ 42 days for bicalutamide)
- A 28-day washout period is not required for patients who have previously progressed despite antiandrogen withdrawal and who have resumed antiandrogens without reduction of PSA
- At least 14 days since prior radiotherapy
- At least 28 days since prior strontium 89
- At least 28 days since prior chemotherapy and/or investigational agents
- No concurrent medications or supplements that contain additional calcium (e.g., Tums)
- No concurrent radiotherapy for pain control or any other indication
- Concurrent bisphosphonates allowed provided dose/regimen is stable
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: Phase II Study of Weekly Intravenous 1,25 Dihydroxycholecelciferol (Calcitriol) + Dexamethasone in Androgen Independent Prostate Cancer
RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with dexamethasone may be an effective treatment for prostate cancer that did not respond to hormone therapy .
PURPOSE: This phase II trial is studying how well giving calcitriol together with dexamethasone works in treating patients with prostate cancer that did not respond to hormone therapy.
Read the detailed description
OBJECTIVES:
- To investigate the response rate in patients with androgen-independent prostate cancer treated with calcitriol and dexamethasone.
- To evaluate the toxicity of high-dose calcitriol and dexamethasone in these patients.
OUTLINE: Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and on days 2 and 3 to assess VDR and CYP24 expression in peripheral blood mononuclear cells.
- Conditions
- Prostate Cancer
- Being tested
- calcitriol, dexamethasone, protein expression analysis, laboratory biomarker analysis
- Keywords
- recurrent 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
IV
dexamethasoneDrug
Oral
protein expression analysisGenetic
Correlative Study
laboratory biomarker analysisOther
Correlative Study
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone and Calcitriol | Experimental | Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly. Receives: Dietary Supplement: calcitriol; Drug: dexamethasone; Genetic: protein expression analysis; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response (Complete or Partial Response)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: 1 year
Secondary outcomes (1)
Corrected Serum Calcium Expression
Number of patients with corrected serum calcium levels between 11 mg/dL and 12 mg/dL detected on 1 or more occasions.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startApr 2006
- Primary completionJul 2010
- Study completionSep 2010
Why it stopped: closed due to futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald L. Trump, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524589
- Sponsor's protocol ID
- CDR0000563197
- Other IDs
- RPCI I-65405
- Status last verified
- Oct 2017
- First submitted
- 31 Aug 2007
- Last updated
- 20 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Weekly Intravenous 1,25 Dihydroxycholecelciferol (Calcitriol) + Dexamethasone in Androgen Independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00524589
- Acronym / sponsor ID
- CDR0000563197
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: closed due to futility
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 3 Sep 2007 (estimated)
- Results
- Posted 10 Mar 2014
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 help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with dexamethasone may be an effective treatment for prostate cancer that did not respond to hormone therapy .
PURPOSE: This phase II trial is studying how well giving calcitriol together with dexamethasone works in treating patients with prostate cancer that did not respond to hormone therapy.
Detailed description
OBJECTIVES:
- To investigate the response rate in patients with androgen-independent prostate cancer treated with calcitriol and dexamethasone.
- To evaluate the toxicity of high-dose calcitriol and dexamethasone in these patients.
OUTLINE: Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and on days 2 and 3 to assess VDR and CYP24 expression in peripheral blood mononuclear cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone and Calcitriol | Experimental | Dietary Supplement: calcitriol, Drug: dexamethasone, Genetic: protein expression analysis, Other: laboratory biomarker analysisPatients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly. |
Who may qualify
- Ages
- Up to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| calcitriolIV | Dietary supplement | Dexamethasone and Calcitriol |
| dexamethasoneOral | Drug | Dexamethasone and Calcitriol |
| protein expression analysisCorrelative Study | Genetic | Dexamethasone and Calcitriol |
| laboratory biomarker analysisCorrelative Study | Other | Dexamethasone and Calcitriol |
Primary outcome
Objective Response (Complete or Partial Response)
Time frame: 1 year
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
1 secondary outcome
Corrected Serum Calcium Expression
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Donald L. Trump, MD principal investigator
Roswell Park 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, dexamethasone and protein expression analysis in people with Prostate Cancer, run by Roswell Park 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: stopped early, as of the sponsor's last update on 20 Nov 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?
Yes. Results are posted in the registry (first posted 10 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response (Complete or Partial Response) (time frame: 1 year). 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 20 Nov 2017.