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

Phase 2
21 Years
83 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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

This is a single arm phase II trial of docetaxel and diethylstilbestrol for patients with
symptomatic stage D3 androgen independent prostate cancer. Patients will receive docetaxel
weekly for 10 cycles (each cycle consists of treatment for 3 weeks out of every 4) and DES
daily for 40 weeks or until there is evidence of disease progression, whichever occurs
first. Patients will be followed to determine PSA and objective response. Additional
endpoints include time to progression, disease specific survival and overall survival.
Disease progression will be defined as 2 consecutive increases in PSA and/or tumor growth as
evidenced by examination or radiologic evaluation. Other secondary objectives will be to
determine the toxicity, and impact on quality of life of this regimen.

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Monthly PSA levels and scans every 3 months while on therapy

Outcome Time Frame:

Over 10 months

Principal Investigator

Bruce Montgomery, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington


United States: Institutional Review Board

Study ID:




Start Date:

December 2002

Completion Date:

October 2007

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Hormone refractory prostate cancer
  • Metastatic prostate cancer
  • Prostatic Neoplasms