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.

Exclusion Criteria:

Patients meeting any of the following criteria will not be eligible for the trial:

* Patients who have received PC-SPES, DES, mitoxantrone or docetaxel therapy.
* Patients who have received prior chemotherapy of any type or are receiving any other investigational therapy.
* Patients with evidence of recent deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure.
* Patients with a prior history of myocardial infarction, pulmonary embolism, cerebral vascular accident (CVA) or atrial fibrillation.
* Patients with evidence of active angina as evidenced by chest pain responsive to sublingual nitroglycerin or other anginal equivalent.
* Patients with known evidence of brain metastases or carcinomatous meningitis.
* Patients with a history of other cancers except curatively-treated non-melanomatous skin cancer. Other cured tumors may be entered after discussion with and approval of the study chair.
* Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
* Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
* Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 must be excluded.
* Histologic evidence of small cell carcinoma of the prostate.
* Patients with current peripheral neuropathy of any etiology that is greater than Grade I.
* Patients with contraindications to anti-coagulation.