Docetaxel and Diethylstilbestrol in the Treatment of Androgen Independent Prostate Cancer

Inclusion Criteria

• •Patients meeting all of the following criteria are eligible for the trial:
• •Men 18 years of age or older with a histologically confirmed diagnosis of adenocarcinoma of the prostate consistent with stage D3.
• •Prior therapy with medical or surgical castration and evidence of castrate levels of testosterone
• •Discontinuation of nonsteroidal antiandrogens more than 6 weeks prior to evaluation for progression. It is not a requirement that nonsteroidal antiandrogen therapy be used prior to enrollment.
• •Androgen independent disease as defined by one of the following after androgen ablation and withdrawal from nonsteroidal antiandrogen if initiated (\> 6 weeks after discontinuation):
• •* PSA must be greater than 5 ng/ml and increasing as demonstrated by two consecutive increasing PSA levels over 5 ng/ml. Each PSA measurement must be taken at least one week apart.
• •* Increase in measurable disease within one month of enrollment
• •* Worsening of bone scan abnormalities within two months of enrollment and greater than four months since initiation of luteinizing hormone-releasing hormone (LHRH) agonist.
• •Performance status \< 3 by the Eastern Cooperative Oncology Group (ECOG) scale.
• •Patients must be informed of the investigational nature of the study and sign an informed consent form.
• •Life expectancy must be \>= 3 months.
• •Laboratory values must be as follows:
• •* White blood cell count: \>= 3,000/mm3
• •* Absolute granulocyte count: \>= 1,500/mm3
• •* Platelets: \>= 100,000/mm3
• •* Hemoglobin: \>= 8g/dL
• •* Serum creatinine: \<= 1.5 x upper limit of normal (ULN)
• •* AST: \<= 2 x ULN
• •* ALT: \<= 2 x ULN
• •* Serum calcium: \<= ULN
• •* Total bilirubin: \<= 1.5 x ULN
• •Patient must be willing to consent to using effective contraception while on treatment and for three months after completion of therapy.