A Phase II Trial of Combination Therapy With Celecoxib and Taxotere for the Treatment of Stage D3 Prostate Cancer
Recruitment status was Recruiting
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.
|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 Combination Therapy With Celecoxib and Taxotere for the Treatment of Stage D3 Prostate Cancer|
- Determine the effect of Taxotere and celecoxib on PSA and objective response in patients with HRPC
- Evaluate the toxicity of the combination of celecoxib and Taxotere in patients with stage D3 prostate cancer.
- Determine the effects of this regimen on quality of life.
- Determine the survival of the patients treated
|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.
|Contact: Basil Kasimis, MD||973-676-1000 ext firstname.lastname@example.org|
|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 email@example.com|
|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|