A Phase II Trial of Combination Therapy With Celecoxib and Taxotere for the Treatment of Stage D3 Prostate Cancer
- 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
- Patients who have evaluable but not measurable disease 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
- 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
- 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
these patients the testosterone level should be preferably checked before enrollment and
should be < 50 ng/dl.
- 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 must not have received prior treatment with chemotherapy within the last 5
- Patients must not have had prior radiotherapy < 4 weeks prior to this protocol
- Patients must not have previously received Strontium 89, Samarium 153, or other
- 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 >
1500/ 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
- Total bilirubin must be within normal limits.
- Creatinine < 2.0 mg/d. or creatinine clearance > 50 ml/min
- Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of
normal (ULN) if alkaline phosphastase is < ULN, or alkaline phosphastase may be up
to 4 x ULN if transaminases are < ULN.
- Peripheral neuropathy must be < grade 1
- 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
- Patients with a history of severe hypersensitivity to Taxotere or other drugs
formulated with polysorbate 80 must be excluded