Prostate CancerPhase 2NCT00394810
Efficacy and Pharmacodynamic Study of Panzem® NCD in Patients With Hormone-Refractory Prostate Cancer
A Phase 2 study testing Panzem® NCD in people with Prostate Cancer, run by CASI pharmaceuticals, Inc. at 4 sites in United States.
Trial summary
This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and pharmacokinetics, of Panzem® NCD in patients with metastatic, docetaxel refractory, androgen-independent 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?
- Panzem® NCD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2006to Nov 2008
- 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
- Patients (pts) must have histologically or cytologically confirmed adenocarcinoma of the prostate.
- Pts must have evidence of progressive metastatic disease (e.g., new lesions on bone scan or new/enlarging lesions on computerized tomography [CT] scan) or known metastatic disease and rising PSA, during or after treatment with a taxane-based regimen (as well as any other subsequent non-cytotoxic therapy).
- Pts with bone metastases only (i.e., lacking soft-tissue disease) must have a PSA level of 10 ng/mL or higher.
- Pts with soft tissue metastases and/or visceral disease must have either measurable disease (per RECIST criteria) or a PSA level of 10 ng/mL or higher.
- For pts with stable metastatic disease and rising PSA: two consecutive rises in PSA measurement are necessary, each separated from the previous by a minimum of two weeks. The most recent PSA value must be obtained within 1 week prior to registration.
- At least 3 PSA values within 6 months of registration (each separated by at least 2 weeks) using the same clinical laboratory needs to be available for calculation of the PSA pre-treatment slope. Only those values obtained after the last treatment date (see inclusion criteria #5 below) will be acceptable.
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- Pts must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy with evidence of treatment failure.
- Pts who have not undergone bilateral orchiectomy must continue their luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist (e.g. abarelix) while receiving protocol therapy.
- A serum testosterone level of 50 ng/dL or lower is required to confirm castration status within 4 weeks prior to study entry.
- For pts previously treated with flutamide (Eulixin), Nilutamide (Nilandron), or bicalutamide (Casodex): pts must have discontinued flutamide 4 weeks or more prior to registration with continued evidence of progressive disease. For bicalutamide or nilutamide, pts must have discontinued the drug 6 weeks or more prior to registration with evidence of progressive disease.
- Disease progression following anti-androgen withdrawal needs to be confirmed by a rising PSA after the required 4-6 week washout period (e.g. PSA level higher than the last PSA obtained while on anti-androgen therapy).
- Pts must have received only one prior taxane-based regimen for metastatic disease, with evidence of disease progression (inclusion criteria #2) during treatment or within 6 months of treatment discontinuation. Up to one other prior experimental therapy (non-cytotoxic) is permitted. At least 4 weeks or more from previous treatment must have elapsed prior to registration, with evidence for disease progression as outlined in inclusion criteria #2.
- Age ≥18 years.
- Life expectancy of greater than 12 weeks.
- Eastern Cooperative Oncology Group [ECOG] performance status of 2 or less
- Pts must have near normal organ and marrow function within 2 weeks prior to registration as defined below:
- Granulocytes > 1500/mm³
- Platelet count > 100,000/mm³
- Bilirubin < 1.5 mg/dL
- Serum glutamate pyruvate transaminase (ALT) < 2 times the institutional upper limit of normal
- Creatinine < 1.5 mg/dL or a calculated creatinine clearance > 50 mL/min
- Pts with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for 5 years or more (excluding non-melanomatous skin cancers treated with curative intent).
- All sites of disease must be evaluated within 4 weeks prior to registration.
- Have the ability to understand the requirements of the study, provide written informed consent and authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments.
Who cannot join
- The use of bisphosphonates (i.e. pamidronate sodium or zoledronic acid) will be allowed provided that the patient has been receiving that medication for 4 weeks or more with evidence of progressive disease as outlined above.
- Pts will not be allowed to start bisphosphonate while receiving protocol treatment unless clinically indicated (will need approval of the study principal investigator). Those patients already on a bisphosphonate will need to continue to receive the bisphosphonate as previously scheduled.
- Pts must not have had prior radiotherapy within 4 weeks prior to registration. Patient cannot have had prior Strontium 89, Samarium 153, or other radioisotope.
- If a pt requires palliative radiotherapy, two consecutive rises (baseline value must be obtained after completion of radiation treatment) in PSA measurement are necessary, each separated from the previous by a minimum of two weeks.
- No concurrent use of estrogen, or estrogen-like agents (i.e. PC-SPES, Saw Palmetto, or other herbal products which may contain phytoestrogens), or any other hormonal therapy (including megastrol acetate, finasteride, ketoconazole, and systemic corticosteroids) is allowed at any time during the study. Prior use of these agents will need to be discontinued 4 weeks or more prior to enrollment. Disease progression needs to be confirmed as outlined in inclusion criteria #2.
- Pts with type I insulin-dependent diabetes or poorly-controlled type II insulin-dependent diabetes or a fasting blood glucose of more than 10 mmol/L (200 mg/dL) will be excluded due to difficulty evaluating the tumor metabolic activity using FDG-PET.
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- Patients must not have active angina pectoris, or known heart disease of New York Heart Association Class III-IV. Patients must not have a history of myocardial infarction within 6 months prior to registration. No history or evidence of ventricular dysrhythmias or other unstable arrythmia is allowed (rate controlled atrial fibrillation is allowed if the patient is asymptomatic from a cardiac standpoint).
- Patients must not have any known history of carcinomatous meningitis or brain metastases.
- No serious concurrent medical illness or active infection should be present which would jeopardize the ability of the patient to receive the therapy outlined in this protocol with reasonable safety.
- No major surgery within 21 days of starting treatment with Panzem NCD.
- Pts must not receive any investigational agents other than Panzem NCD for the duration of their participation in this trial.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Indiana University Cancer Center
Indianapolis, Indiana, 46202
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: Phase 2 Efficacy and Pharmacodynamic Study of 2-Methoxyestradiol Nanocrystal Colloidal Dispersion(Panzem® NCD) in Patients With Taxane-Refractory, Metastatic,Hormone-Refractory Prostate Cancer
This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and pharmacokinetics, of Panzem® NCD in patients with metastatic, docetaxel refractory, androgen-independent prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Panzem® NCD
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panzem® NCDDrug
suspension, 100 mg/mL, four times daily continuous dosing
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Panzem® NCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 month progression free survival
Measured: at time of progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionNov 2008
- Study completionNov 2008
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- CASI pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Glenn Liu, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394810
- Sponsor's protocol ID
- ME-CLN-006
- Status last verified
- Nov 2008
- First submitted
- 30 Oct 2006
- Last updated
- 25 Nov 2008
- Results posted
- No
Publications
Harrison MR, Hahn NM, Pili R, Oh WK, Hammers H, Sweeney C, Kim K, Perlman S, Arnott J, Sidor C, Wilding G, Liu G. A phase II study of 2-methoxyestradiol (2ME2) NanoCrystal(R) dispersion (NCD) in patients with taxane-refractory, metastatic castrate-resistant prostate cancer (CRPC). Invest New Drugs. 2011 Dec;29(6):1465-74. doi: 10.1007/s10637-010-9455-x. Epub 2010 May 25.
PubMed 20499131
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Efficacy and Pharmacodynamic Study of 2-Methoxyestradiol Nanocrystal Colloidal Dispersion(Panzem® NCD) in Patients With Taxane-Refractory, Metastatic,Hormone-Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00394810
- Acronym / sponsor ID
- ME-CLN-006
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- CASI pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 1 Nov 2006 (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.
This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and pharmacokinetics, of Panzem® NCD in patients with metastatic, docetaxel refractory, androgen-independent prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Panzem® NCD |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patients (pts) must have histologically or cytologically confirmed adenocarcinoma of the prostate.
- Pts must have evidence of progressive metastatic disease (e.g., new lesions on bone scan or new/enlarging lesions on computerized tomography [CT] scan) or known metastatic disease and rising PSA, during or after treatment with a taxane-based regimen (as well as any other subsequent non-cytotoxic therapy).
- Pts must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy with evidence of treatment failure.
- For pts previously treated with flutamide (Eulixin), Nilutamide (Nilandron), or bicalutamide (Casodex): pts must have discontinued flutamide 4 weeks or more prior to registration with continued evidence of progressive disease. For bicalutamide or nilutamide, pts must have discontinued the drug 6 weeks or more prior to registration with evidence of progressive disease.
- Pts must have received only one prior taxane-based regimen for metastatic disease, with evidence of disease progression (inclusion criteria #2) during treatment or within 6 months of treatment discontinuation. Up to one other prior experimental therapy (non-cytotoxic) is permitted. At least 4 weeks or more from previous treatment must have elapsed prior to registration, with evidence for disease progression as outlined in inclusion criteria #2.
Key exclusion criteria (11 listed)
- The use of bisphosphonates (i.e. pamidronate sodium or zoledronic acid) will be allowed provided that the patient has been receiving that medication for 4 weeks or more with evidence of progressive disease as outlined above.
- Pts must not have had prior radiotherapy within 4 weeks prior to registration. Patient cannot have had prior Strontium 89, Samarium 153, or other radioisotope.
- No concurrent use of estrogen, or estrogen-like agents (i.e. PC-SPES, Saw Palmetto, or other herbal products which may contain phytoestrogens), or any other hormonal therapy (including megastrol acetate, finasteride, ketoconazole, and systemic corticosteroids) is allowed at any time during the study. Prior use of these agents will need to be discontinued 4 weeks or more prior to enrollment. Disease progression needs to be confirmed as outlined in inclusion criteria #2.
- Pts with type I insulin-dependent diabetes or poorly-controlled type II insulin-dependent diabetes or a fasting blood glucose of more than 10 mmol/L (200 mg/dL) will be excluded due to difficulty evaluating the tumor metabolic activity using FDG-PET.
- Patients must not have active angina pectoris, or known heart disease of New York Heart Association Class III-IV. Patients must not have a history of myocardial infarction within 6 months prior to registration. No history or evidence of ventricular dysrhythmias or other unstable arrythmia is allowed (rate controlled atrial fibrillation is allowed if the patient is asymptomatic from a cardiac standpoint).
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 |
|---|---|---|
| Panzem® NCDsuspension, 100 mg/mL, four times daily continuous dosing | Drug | 1 |
Primary outcome
6 month progression free survival
Time frame: at time of progression
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 25 Nov 2008.
- Derived from this study: PubMed 20499131Harrison MR, Hahn NM, Pili R, Oh WK, Hammers H, Sweeney C, Kim K, Perlman S, Arnott J, Sidor C, Wilding G, Liu G. A phase II study of 2-methoxyestradiol (2ME2) NanoCrystal(R) dispersion (NCD) in patients with taxane-refractory, metastatic castrate-resistant prostate cancer (CRPC). Invest New Drugs. 2011 Dec;29(6):1465-74. doi: 10.1007/s10637-010-9455-x. Epub 2010 May 25.
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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.
Glenn Liu, MD principal investigator
University of Wisconsin, Madison
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Panzem® NCD in people with Prostate Cancer, run by CASI pharmaceuticals, Inc. at 4 sites 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 24 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 25 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
6 month progression free survival (time frame: at time of progression). 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 NCT00394810, 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 25 Nov 2008.