Prostate CancerPhase 1NCT00004928
Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer
A Phase 1 study testing calcitriol and zoledronic acid in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Calcitriol may help prostate cancer cells develop into normal cells. Zoledronate may delay or prevent the formation of bone metastases. Combining calcitriol and zoledronate may be an effective treatment for progressive prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- calcitriol and zoledronic acid
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Oct 2004
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed prior localized adenocarcinoma of the prostate that has undergone definitive radiation or surgery and demonstrates progression biochemically with all of the following:
- Baseline PSA at least 4 ng/mL
- At least a 50% increase in PSA over at least 3 determinations taken at more than 2 week intervals
- No radiographically evident disease
- Neoadjuvant hormonal therapy prior to radical prostatectomy or radiotherapy allowed
- Treatment in an intermittent approach allowed if off therapy for at least 12 weeks OR
- Histologically confirmed androgen-independent adenocarcinoma of the prostate with all of the following:
- Progression on primary hormonal treatment (e.g., orchiectomy, estrogen therapy, gonadotropin-releasing hormone analog with or without an antiandrogen) with either new osseous lesions in bone, a greater than 25% increase in bidimensionally measurable tumor mass, or rising PSA values (rising PSA on any 3 determinations taken at at least weekly intervals, to greater than 50% above baseline PSA) despite castrate levels of testosterone (no greater than 30 ng/mL)
- If receiving antiandrogen as part of primary hormonal therapy, must meet criteria above for progression after discontinuation of antiandrogen
- No change in hormonal therapy (including prednisone or dexamethasone) within the past 2 weeks
- If no prior surgical orchiectomy, must continue on medical therapies to maintain castrate levels of testosterone
- Prior chemotherapy, palliative radiotherapy, or radioisotope treatment allowed
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC at least 3,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 2.0 mg/dL OR
- SGOT less than 3 times upper limit of normal
Renal:
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
- No history of nephrolithiasis
- Must have 2 functioning kidneys
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Pulmonary:
- No severe debilitating pulmonary disease
Metabolic:
- No pre-existing endocrine or metabolic disorders that impact calcium regulatory axis including hypercalcemia (ionized serum calcium greater than 5.3 mg/dL or total calcium greater than 10.5 mg/dL) or hypercalciuria (greater than 300 mg urinary calcium/24 hours)
Other:
- No active secondary malignancy except nonmelanoma skin cancer
- Must maintain low calcium diet (less than 800 mg calcium daily)
- No uncontrolled serious active infection
- No history of malabsorption disorders
- No history of inflammatory bowel disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy and recovered
- No concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- Recovered from prior endocrine therapy
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy to sole measurable lesion
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
- No concurrent surgery to sole measurable lesion
Other:
- No other concurrent cholecalciferol
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase I Study of 1,25 Dihydroxy-Vitamin D3 (Calcitriol) in Patients With Prostate Cancer
RATIONALE: Calcitriol may help prostate cancer cells develop into normal cells. Zoledronate may delay or prevent the formation of bone metastases. Combining calcitriol and zoledronate may be an effective treatment for progressive prostate cancer.
PURPOSE: Phase I trial to study the effectiveness of combining calcitriol with zoledronate in treating patients who have progressive prostate cancer.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of calcitriol administered with zoledronate in patients with progressive prostate cancer.
- Assess the effects of this regimen on calcium homeostasis and bone turnover in this patient population.
- Assess changes in PSA in patients treated with this regimen.
- Determine other antitumor effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study of calcitriol.
Patients receive oral calcitriol weekly for 3 consecutive days and zoledronate IV monthly. Treatment continues in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.
- Conditions
- Prostate Cancer
- Being tested
- calcitriol, zoledronic acid
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, 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
zoledronic acidDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2003 (estimated)
- Study startOct 1999
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Michael Morris, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004928
- Sponsor's protocol ID
- 99-073
- Other IDs
- CDR0000067612, NCI-H00-0048
- Status last verified
- Jun 2013
- First submitted
- 7 Mar 2000
- Last updated
- 19 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of 1,25 Dihydroxy-Vitamin D3 (Calcitriol) in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00004928
- Acronym / sponsor ID
- 99-073
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 1999
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 14 May 2003 (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 help prostate cancer cells develop into normal cells. Zoledronate may delay or prevent the formation of bone metastases. Combining calcitriol and zoledronate may be an effective treatment for progressive prostate cancer.
PURPOSE: Phase I trial to study the effectiveness of combining calcitriol with zoledronate in treating patients who have progressive prostate cancer.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of calcitriol administered with zoledronate in patients with progressive prostate cancer.
- Assess the effects of this regimen on calcium homeostasis and bone turnover in this patient population.
- Assess changes in PSA in patients treated with this regimen.
- Determine other antitumor effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study of calcitriol.
Patients receive oral calcitriol weekly for 3 consecutive days and zoledronate IV monthly. Treatment continues in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- 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 | – |
| zoledronic acid | Drug | – |
Primary outcome
Not reported in the source record.
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 19 Jun 2013.
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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.
Michael Morris, MD study chair
Memorial Sloan Kettering Cancer Center
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 calcitriol and zoledronic acid in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center 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 19 Jun 2013. 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.
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 19 Jun 2013.