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| Sponsor: | Department of Veterans Affairs, New Jersey |
|---|---|
| Collaborators: |
Pfizer Sanofi-Aventis |
| Information provided by: | Department of Veterans Affairs, New Jersey |
| ClinicalTrials.gov Identifier: | NCT00215345 |
Purpose
The purpose of this clinical trial is to find out the safety and effectiveness as well as patient’s quality of life on the combination of Taxotere and celecoxib on patients with hormone refractory prostate cancer. Celecoxib (Celebrex) is an FDA approved drug to treat arthritis. Taxotere (Docetaxel) is an FDA approved chemotherapy drug to treat certain forms of cancer. Both drugs have demonstrated evidences of tumor blood vessel suppression and combination of these two drugs could possibly arrest further tumor growth or make the tumor decrease in size.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Taxotere 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 Combination Therapy With Celecoxib and Taxotere for the Treatment of Stage D3 Prostate Cancer |
| Estimated Enrollment: | 66 |
| Study Start Date: | August 2002 |
| Estimated Study Completion Date: | December 2006 |
The standard hormone therapy for patients with metastases is androgen deprivation. This treatment leads to response in 75-80% of the patients, with median duration of response of only 14-18 months. Once the patient becomes hormone resistant, there is no effective therapy to prolong life. For patients with HRPC, the median life expectancy is 17 months.2 Thus palliative care remains the standard therapy for HRPC. The most widely used chemotherapy regimens are combinations of mitoxantrone with prednisone and taxanes with estramustine phosphate.3,4,5 Taxotere has also demonstrated activity in prostate cancer cell lines.6 Several clinical studies have demonstrated its activity in patients with metastatic prostate cancer as a single agent or in combination.4, 5 Taxotere may exert its effects in part through anti-angiogenic effects.7 Recent work in animal models has provided additional evidence for the beneficial role of angiostatic agents in the treatment of malignant diseases. This is the first study of the two drugs used together in prostate cancer.
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. For these patients the testosterone level should be preferably checked before enrollment and should be < 50 ng/dl.
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
| Study ID Numbers: | COXAON-0509-047, GIA16125 |
| Study First Received: | September 20, 2005 |
| Last Updated: | September 20, 2005 |
| ClinicalTrials.gov Identifier: | NCT00215345 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Celecoxib Taxotere Hormone Refractory Prostate Cancer |
|
Anti-Inflammatory Agents Celecoxib Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Urogenital Neoplasms Genital Diseases, Male Pharmacologic Actions |
Docetaxel Neoplasms Neoplasms by Site Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Prostatic Neoplasms |