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.
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:
Basil Kasimis, MD, Phone: 973-676-1000, Ext: 1544, Email: basil.kasimis@med.va.gov
