Docetaxel and Diethylstilbestrol in the Treatment of Androgen Independent Prostate Cancer: A Phase II Study

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.