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A Pilot Study of Docetaxel on a Bi-Weekly Schedule in the Treatment of Elderly Men With Hormone-Refractory Prostate Cancer (HRPC)

Phase 1
65 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

A Pilot Study of Docetaxel on a Bi-Weekly Schedule in the Treatment of Elderly Men With Hormone-Refractory Prostate Cancer (HRPC)

The information obtained from this trial will help determine the feasibility and safety of
administering docetaxel at various dosing levels on a bi-weekly schedule in this patient
population. If the data from this phase I trial are encouraging, a phase II trial will be
conducted to further assess the efficacy of this dosing schedule.

Inclusion Criteria:

- age ≥ 65 years;

- histologically confirmed adenocarcinoma of the prostate;

- metastatic disease;

- unresponsive or refractory to hormonal therapy, as defined by at least 1 of the
following criteria: progression of bidimensionally measurable disease; progression of
evaluable but not measurable disease (bone scan); at least 2 consecutive rises in PSA
at least 1 week apart;

- patients must have serum testosterone levels < 50 ng/mL at time of study entry. For
patients who are medically castrated, lutenizing hormone releasing hormone analog
must continue to maintain testicular suppression;

- prior nonsteroidal antiandrogens (flutamide, ketoconazole, bicalutamide, or
nilutamide) allowed if disease progression occurred. No evidence of response after
antiandrogen withdrawal within 4 weeks for patients treated with flutamide,
ketoconazole, nilutamide and 6 weeks for patients treated with bicalutamide;

- chemotherapy naïve;

- full recovery from the effects of any prior surgery or radiation therapy. At least 4
weeks since any radiation therapy;

- ECOG performance status 0-2;

- adequate kidney, liver, and bone marrow functions;

- signed study-specific informed consent form.

Exclusion Criteria:

- Concurrent chemotherapy or immunotherapy;

- Patients who have received an investigational drug within 4 weeks of registration;

- Prior or concurrent malignancies (other than surgically treated carcinoma in situ of
the cervix and squamous or basal cell carcinoma of the skin) within the preceding
five years;

- Serious medical or psychiatric illness which would prevent informed consent;

- Life expectancy < 3 months;

- Active uncontrolled bacterial, viral, or fungal infection until these conditions are
corrected or controlled;

- Known hypersensitivity to study drug or to other drugs formulated with polysorbate

Type of Study:


Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose (MTD) of docetaxel on a bi-weekly schedule in the treatment of elderly men with hormonal refractory prostate cancer (HRPC).

Principal Investigator

William Ershler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Geriatric Oncology Consortium


United States: Institutional Review Board

Study ID:

GOC GU-010



Start Date:

July 2004

Completion Date:

July 2007

Related Keywords:

  • Prostate Cancer
  • elderly
  • Prostatic Neoplasms



Baltimore, Maryland  21287