Prostate CancerPhase 2NCT00218205
A Study of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Prostate Cancer
A Phase 2 study testing Epirubicin, Estramustine Phosphate and Celecoxib in people with Prostate Cancer, run by Department of Veterans Affairs, New Jersey at 1 site in United States.
Trial summary
The purpose of this clinical trial is to find out the effect of epirubicin with estramustine phosphate and celecoxib on PSA and objective response in patients with hormone resistant prostate cancer as well as evaluating the toxicity, quality of life of this combination. 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?
- Epirubicin, Estramustine Phosphate and Celecoxib
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Jun 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have histologically proven adenocarcinoma of the prostate gland.
- Patient must have evidence of progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver or lung metastases) within 6 weeks prior to participation in the study.
- Patients must not have an elevated PSA level as the only evidence of disease. While castrated, the patients should have rising PSA on two consecutive measurements at least 1 week apart. The confirmatory PSA must be obtained within 1 week prior to study registration and should be >10ng/ml.
- Patients with bone metastases only (i.e., lacking soft-tissue disease) must have a PSA level of > 10 ng/ml. Patients with soft tissue metastases and /or visceral disease must have either measurable disease or a PSA level of > 10 ng/ml.
- Radiological evidence of hydronephrosis will not by itself constitute evidence of metastatic disease.
- Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (e.g., estrogen therapy, LHRH analog + flutamide, etc.) with evidence of treatment failure.
Show all 25Show fewer
- NOTE: Patients who have not undergone bilateral orchiectomy must continue LHRH agonist therapy (e.g., depot leuprolide or goserelin) while receiving this protocol therapy.
- For patients previously treated with flutamide (Eulexin), nilutamide (Nilandron), or bicalutamide (Casodex): Patients must have discontinued flutamide or nilutamide < 4 weeks and for bicalutamide 6 weeks prior to registration.
- Patients should not have prior exposure to anthracyclines or estramustine phosphate.
- Patients must not have had prior radiotherapy < 4 weeks prior to this protocol treatment.
- Patients must not have previously received Strontium 89, Samarium 153, or other radioisotope therapies.
- Patients must have recovered from all toxicities due to prior treatment for prostate cancer prior to receiving this protocol treatment.
- Patients must have adequate bone marrow function: (WBC > 4000/ mm3, granulocytes > 2000/ mm3, platelet count > 100,000/mm3, and Hemoglobin > 8.0 g/dl < 4 weeks prior to participate in this study.
- Patients must have the following chemistry values < 4 weeks prior to participate in this study:
- Bilirubin < 1.5 mg/dl
- Transaminases (SGOT and/or SGPT) < 5 x institutional upper limit of normal (ULN)
- Creatinine < 2.0 mg/d. or creatinine clearance > 50 ml/min
- Alkaline phosphatase £ 5 x ULN
- Patients must have no active angina pectoris, or known heart disease of New York Heart Association Class III-IV. Patients must not have a history of myocardial infarction < 6 months prior to the study participation.
- Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for the specific cancer.
- No serious concurrent medical illness or active infection should be present which would jeopardize the ability of the patient to receive the chemotherapy outlined in this protocol with reasonable safety.
- Sexually active patients must use an accepted and effective method of contraception while receiving protocol treatment.
- Patients must have a Karnofsky Performance Scale (KPS) score over 50. (Equaling ECOG Performance Scale of 0, 1, or 2).
- Age > 18 years.
- Patient must have failed the Taxotere treatment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Department of Veterans Affairs NJ Health Care System
East Orange, New Jersey, 07018
Basil Kasimis, MD, 973-676-1000 ext. 1544, basil.kasimis@med.va.gov
Victor Chang, MD
About this study
Official title: A Phase II Trial of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Hormone Resistant Prostate Cancer (HRPC)
The purpose of this clinical trial is to find out the effect of epirubicin with estramustine phosphate and celecoxib on PSA and objective response in patients with hormone resistant prostate cancer as well as evaluating the toxicity, quality of life of this combination. Celecoxib is an FDA approved drug to treat arthritis. Epirubicin, alone or with estramustine phosphate has been used in the treatment of hormone resistant prostate cancer. These drugs have demonstrated evidences of tumor blood vessel suppression and combination of these three drugs could possibly arrest further tumor growth or even make the tumor decrease in size.
- Conditions
- Prostate Cancer
- Being tested
- Epirubicin, Estramustine Phosphate, Celecoxib
- Keywords
- Epirubicin, Estramustine Phosphate, Celecoxib, Hormone Refractory 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.
EpirubicinDrug
Estramustine PhosphateDrug
CelecoxibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of epirubicin with estramustine phosphate and celecoxib on PSA and objective response in patients with HRPC
Secondary outcomes (3)
Evaluate the toxicity of the combination of epirubicin with estramustine phosphate and celecoxib in patients with stage D3 prostate cancer.
Determine the effects of this regimen on quality of life.
Determine the survival of the patients treated with the proposed regimen.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2002
- Study completionJun 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.
- 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
- 28 participants
Sponsor and investigators
- Lead sponsor
- Department of Veterans Affairs, New Jersey
- Sponsor type
- US federal agency
- Collaborators
- Pfizer
- Investigators
- Basil Kasimis, MD, Principal investigator, Department of Veterans Affairs NJ Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218205
- Sponsor's protocol ID
- K-EPIRU-0030-280-US
- Status last verified
- Sep 2005
- First submitted
- 20 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Publications
Zhong F, Kasimis B, Hwang S, Cogswell J, Chang V, Morales E, Gonzalez M, Boholli I, Ohanian M, Blumenfrucht M: Second Line Treatment of Hormone Resistant Prostate Cancer (HRPC). A Phase II Trial of Epirubicin (E), Estramustine Phosphate (EP) and Celecoxib © Proc Am Soc Clin Oncol, Vol 24 #4754, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Hormone Resistant Prostate Cancer (HRPC)
- ClinicalTrials.gov ID
- NCT00218205
- Acronym / sponsor ID
- K-EPIRU-0030-280-US
- Conditions
- Prostate Cancer
- Keywords
- Epirubicin, Estramustine Phosphate, Celecoxib, Hormone Refractory Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants
- Lead sponsor
- Department of Veterans Affairs, New JerseyUS federal agency
- Collaborators
- Pfizer
- Study start
- Jul 2002
- Study completion
- Jun 2006
- First posted
- 22 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.
The purpose of this clinical trial is to find out the effect of epirubicin with estramustine phosphate and celecoxib on PSA and objective response in patients with hormone resistant prostate cancer as well as evaluating the toxicity, quality of life of this combination. Celecoxib is an FDA approved drug to treat arthritis. Epirubicin, alone or with estramustine phosphate has been used in the treatment of hormone resistant prostate cancer. These drugs have demonstrated evidences of tumor blood vessel suppression and combination of these three drugs could possibly arrest further tumor growth or even make the tumor decrease in size.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Patient must have histologically proven adenocarcinoma of the prostate gland.
- Patient must have evidence of progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver or lung metastases) within 6 weeks prior to participation in the study.
- Patients must not have an elevated PSA level as the only evidence of disease. While castrated, the patients should have rising PSA on two consecutive measurements at least 1 week apart. The confirmatory PSA must be obtained within 1 week prior to study registration and should be >10ng/ml.
- Patients with bone metastases only (i.e., lacking soft-tissue disease) must have a PSA level of > 10 ng/ml. Patients with soft tissue metastases and /or visceral disease must have either measurable disease or a PSA level of > 10 ng/ml.
- Radiological evidence of hydronephrosis will not by itself constitute evidence of metastatic disease.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Epirubicin | Drug | – |
| Estramustine Phosphate | Drug | – |
| Celecoxib | Drug | – |
Primary outcome
Determine the effect of epirubicin with estramustine phosphate and celecoxib on PSA and objective response in patients with HRPC
3 secondary outcomes
Evaluate the toxicity of the combination of epirubicin with estramustine phosphate and celecoxib in patients with stage D3 prostate cancer.
Determine the effects of this regimen on quality of life.
Determine the survival of the patients treated with the proposed regimen.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2005.
- Results publicationZhong F, Kasimis B, Hwang S, Cogswell J, Chang V, Morales E, Gonzalez M, Boholli I, Ohanian M, Blumenfrucht M: Second Line Treatment of Hormone Resistant Prostate Cancer (HRPC). A Phase II Trial of Epirubicin (E), Estramustine Phosphate (EP) and Celecoxib © Proc Am Soc Clin Oncol, Vol 24 #4754, 2005.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Basil Kasimis, MD principal investigator
Department of Veterans Affairs NJ Health Care System
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 Epirubicin, Estramustine Phosphate and Celecoxib in people with Prostate Cancer, run by Department of Veterans Affairs, New Jersey 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 25 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 22 Sep 2005. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Basil Kasimis, MD (973-676-1000 ext. 1544, basil.kasimis@med.va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the effect of epirubicin with estramustine phosphate and celecoxib on PSA and objective response in patients with HRPC. 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 NCT00218205, 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 22 Sep 2005.