Prostate CancerPhase 2NCT00582582
Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer
A Phase 2 study testing Docetaxel plus doxercalciferol in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this research study is to find out the toxicities of doxercalciferol given in combination with docetaxel (Taxotere®), as well as to see how well this combination works in the treatment of 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?
- Docetaxel plus doxercalciferol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Apr 2007
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of adenocarcinoma of the prostate.
- evidence of metastatic disease within 4 weeks of registration.
- Must meet ONE of the following:
- PSA >or= 10 ng/mL and at least one lesion on bone scan.
- Soft tissue metastases and/or visceral disease per CT scan.
- Must show progressing prostate cancer as seen by one of the following:
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- At least one new lesion on bone scan,
- Increase in size or number of measurable disease lesions,
- At least 2 rising PSA measurements at least two weeks apart.
- Prior bilateral orchiectomy or on LHRH agonist therapy with a serum testosterone level of < 50.
- Must be off flutamide, nilutamide, or ketoconazole or herbal supplements used to treat prostate cancer at least 4 weeks prior to registration and bicalutamide at least 6 weeks prior to registration.
- No prior cytotoxic chemotherapy.
- WHO performance status of 0-2.
- Peripheral neuropathy must be < or = to grade 1.
Who cannot join
- A history of a radiographically confirmed kidney stone or pathologically confirmed calcium stone within the last 10 years.
- Patients can continue to take bisphosphonates during the study as long as the bisphosphonate was started at least 4 weeks prior to study entry and the patient continues to demonstrate a rising PSA
- No prior treatment with suramin, strontium or other therapeutic radioisotopes.
- No radiotherapy within the past 4 weeks.
- No known brain metastases.
- No chronic hypercalcemia (serum calcium >1.0 mg/dl above the upper limit of normal range), chronic gastrointestinal disease (malabsorption, surgery affecting absorption, chronic ulcerative colitis) or any condition that the investigator feels would put the patient at undue risk.
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- Must not be taking digitalis, thiazide diuretics (or drugs in combination with thiazides) or calcium supplements within one week of treatment initiation.
- No active angina, known heart disease of New York Heart Association Class II-IV or a recent history (< 6 months) of myocardial infarction.
- Must not be taking steroids, anticonvulsants, fluoride, or lithium.
- Must not have urinary protein > 4gm/24 hours
- Must not have urinary calcium > or= 500 mg/24 hours
- No Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin
Madison, Wisconsin, 53792-5669
About this study
Official title: Phase II Evaluation of Docetaxel Randomized With Doxercalciferol or Placebo in Patients With Advanced Prostate Cancer
The purpose of this research study is to find out the toxicities of doxercalciferol given in combination with docetaxel (Taxotere®), as well as to see how well this combination works in the treatment of prostate cancer.
Read the detailed description
This is a multi-institutional, double-blinded, randomized study comparing docetaxel plus doxercalciferol versus docetaxel plus placebo in patients with metastatic hormone refractory prostate cancer. Docetaxel is given intravenously on days 1, 8 and 15 for every 28 day cycle and doxercalciferol or placebo is taken orally every day of the 28 day cycle. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.
- Conditions
- Prostate Cancer
- Being tested
- Docetaxel plus doxercalciferol, Docetaxel plus placebo
- Keywords
- Metastatic, Hormone Refractory, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel plus doxercalciferolDrug
Also called Taxotere, Hectoral, 1a,hydroxyvitamin D2, 1a-OH-D2
Docetaxel 35mg/m2 IV weekly x3 every 4 weeks plus Doxercalciferol 10mcg orally every day
Docetaxel plus placeboDrug
Also called Taxotere
Docetaxel 35mg/m2 IV weekly x3 every 4 week cycle plus placebo taken orally every day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Docetaxel plus doxercalciferol Receives: Drug: Docetaxel plus doxercalciferol |
| B | Placebo comparator | Docetaxel plus placebo Receives: Drug: Docetaxel plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: At 12 weeks on study
Secondary outcomes (1)
Safety
Measured: Duration of study participation through 30 days post last treatment dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startApr 2002
- Study completionApr 2007
Why it stopped: Lack of drug supply for doxercalciferol for this study
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 University of Wisconsin, MadisonThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- George Wilding, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582582
- Sponsor's protocol ID
- HSC 2001-484
- Other IDs
- CO01802
- Status last verified
- Apr 2009
- First submitted
- 19 Dec 2007
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of Docetaxel Randomized With Doxercalciferol or Placebo in Patients With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT00582582
- Acronym / sponsor ID
- HSC 2001-484
- Conditions
- Prostate Cancer
- Keywords
- Metastatic, Hormone Refractory, Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of drug supply for doxercalciferol for this study
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Sanofi, Genzyme, a Sanofi Company
- Study start
- Apr 2002
- Study completion
- Apr 2007 (actual)
- First posted
- 28 Dec 2007 (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.
The purpose of this research study is to find out the toxicities of doxercalciferol given in combination with docetaxel (Taxotere®), as well as to see how well this combination works in the treatment of prostate cancer.
Detailed description
This is a multi-institutional, double-blinded, randomized study comparing docetaxel plus doxercalciferol versus docetaxel plus placebo in patients with metastatic hormone refractory prostate cancer. Docetaxel is given intravenously on days 1, 8 and 15 for every 28 day cycle and doxercalciferol or placebo is taken orally every day of the 28 day cycle. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Docetaxel plus doxercalciferolDocetaxel plus doxercalciferol |
| B | Placebo comparator | Drug: Docetaxel plus placeboDocetaxel plus placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologic diagnosis of adenocarcinoma of the prostate.
- evidence of metastatic disease within 4 weeks of registration.
- Must meet ONE of the following:
- Must show progressing prostate cancer as seen by one of the following:
- Prior bilateral orchiectomy or on LHRH agonist therapy with a serum testosterone level of < 50.
Key exclusion criteria (12 listed)
- A history of a radiographically confirmed kidney stone or pathologically confirmed calcium stone within the last 10 years.
- Patients can continue to take bisphosphonates during the study as long as the bisphosphonate was started at least 4 weeks prior to study entry and the patient continues to demonstrate a rising PSA
- No prior treatment with suramin, strontium or other therapeutic radioisotopes.
- No radiotherapy within the past 4 weeks.
- No known brain metastases.
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 plus doxercalciferolAlso: Taxotere, Hectoral, 1a,hydroxyvitamin D2, 1a-OH-D2Docetaxel 35mg/m2 IV weekly x3 every 4 weeks plus Doxercalciferol 10mcg orally every day | Drug | A |
| Docetaxel plus placeboAlso: TaxotereDocetaxel 35mg/m2 IV weekly x3 every 4 week cycle plus placebo taken orally every day | Drug | B |
Primary outcome
Objective response rate
Time frame: At 12 weeks on study
1 secondary outcome
Safety
Time frame: Duration of study participation through 30 days post last treatment dose
Results and safety
The study was stopped early (reason given: Lack of drug supply for doxercalciferol for this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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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.
George Wilding, MD principal investigator
University of Wisconsin, Madison
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 Docetaxel plus doxercalciferol in people with Prostate Cancer, run by University of Wisconsin, Madison 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 14 inclusion and 12 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: stopped early, as of the sponsor's last update on 13 Dec 2019. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Lack of drug supply for doxercalciferol for this study). Results are not available in the source record.
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 rate (time frame: At 12 weeks on study). 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 13 Dec 2019.