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| Sponsor: | Department of Veterans Affairs, New Jersey |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | Department of Veterans Affairs, New Jersey |
| ClinicalTrials.gov Identifier: | NCT00218205 |
Purpose
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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00218205 History of Changes |
| Other Study ID Numbers: | K-EPIRU-0030-280-US |
| Study First Received: | September 20, 2005 |
| Last Updated: | September 20, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Epirubicin Estramustine Phosphate Celecoxib Hormone Refractory Prostate Cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Estramustine Epirubicin Celecoxib Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating |
Alkylating Agents Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Central Nervous System Agents Antirheumatic Agents |