- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00218205
A Study of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Prostate Cancer
September 20, 2005 updated by: Department of Veterans Affairs, New Jersey
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
28
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Basil Kasimis, MD
- Phone Number: 1544 973-676-1000
- Email: basil.kasimis@med.va.gov
Study Locations
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New Jersey
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East Orange, New Jersey, United States, 07018
- Recruiting
- Department Of Veterans Affairs NJ Health Care System
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Contact:
- Basil Kasimis, MD
- Phone Number: 1544 973-676-1000
- Email: basil.kasimis@med.va.gov
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Sub-Investigator:
- Victor Chang, MD
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Sub-Investigator:
- Shanthi Srinivas, MD
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Sub-Investigator:
- Fengming Zhong, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
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.
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Determine the effect of epirubicin with estramustine phosphate and celecoxib on PSA and objective response in patients with HRPC
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Secondary Outcome Measures
Outcome Measure |
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Evaluate the toxicity of the combination of epirubicin with estramustine phosphate and celecoxib in patients with stage D3 prostate cancer.
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Determine the effects of this regimen on quality of life.
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Determine the survival of the patients treated with the proposed regimen.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Basil Kasimis, MD, Department Of Veterans Affairs NJ Health Care System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Study Completion
June 1, 2006
Study Registration Dates
First Submitted
September 20, 2005
First Submitted That Met QC Criteria
September 20, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
September 22, 2005
Last Update Submitted That Met QC Criteria
September 20, 2005
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cyclooxygenase 2 Inhibitors
- Epirubicin
- Celecoxib
- Estramustine
Other Study ID Numbers
- K-EPIRU-0030-280-US
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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