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Sponsors and Collaborators: |
Department of Veterans Affairs, New Jersey Pfizer |
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Information provided by: | Department of Veterans Affairs, New Jersey |
ClinicalTrials.gov Identifier: | NCT00218205 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Epirubicin Drug: Estramustine Phosphate Drug: Celecoxib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Hormone Resistant Prostate Cancer (HRPC) |
Estimated Enrollment: | 28 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | June 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
NOTE: Patients who have not undergone bilateral orchiectomy must continue LHRH agonist therapy (e.g., depot leuprolide or goserelin) while receiving this protocol therapy.
Exclusion Criteria:
Contact: Basil Kasimis, MD | 973-676-1000 ext 1544 | basil.kasimis@med.va.gov |
United States, New Jersey | |
Department of Veterans Affairs NJ Health Care System | Recruiting |
East Orange, New Jersey, United States, 07018 | |
Contact: Basil Kasimis, MD 973-676-1000 ext 1544 basil.kasimis@med.va.gov | |
Sub-Investigator: Victor Chang, MD | |
Sub-Investigator: Shanthi Srinivas, MD | |
Sub-Investigator: Fengming Zhong, MD |
Principal Investigator: | Basil Kasimis, MD | Department of Veterans Affairs NJ Health Care System |
Study ID Numbers: | K-EPIRU-0030-280-US |
Study First Received: | September 20, 2005 |
Last Updated: | September 20, 2005 |
ClinicalTrials.gov Identifier: | NCT00218205 |
Health Authority: | United States: Food and Drug Administration |
Epirubicin Estramustine Phosphate Celecoxib Hormone Refractory Prostate Cancer |
Celecoxib Prostatic Diseases Genital Neoplasms, Male Estramustine |
Urogenital Neoplasms Genital Diseases, Male Epirubicin Prostatic Neoplasms |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Antibiotics, Antineoplastic Pharmacologic Actions Neoplasms Neoplasms by Site |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antineoplastic Agents, Alkylating Antirheumatic Agents Central Nervous System Agents Alkylating Agents |