Bi-Weekly Administration of Docetaxel for Older Men With Hormone Refractory Prostate Cancer

This study has been completed.
Information provided by:
Geriatric Oncology Consortium Identifier:
First received: September 19, 2005
Last updated: November 15, 2007
Last verified: November 2007

This pilot study is designed to determine the feasibility and safety of administering docetaxel at various dosing levels on a bi-weekly schedule in older men with hormone refractory prostate cancer.

Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Docetaxel on a Bi-Weekly Schedule in the Treatment of Elderly Men With Hormone-Refractory Prostate Cancer (HRPC)

Resource links provided by NLM:

Further study details as provided by Geriatric Oncology Consortium:

Primary Outcome Measures:
  • 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).

Secondary Outcome Measures:
  • To determine the dose limiting toxicity effects and other toxic effects of this regimen
  • To determine the activity of this regimen in terms of: Overall response rates; Pain scores and analgesic use; PSA response rates;
  • To evaluate the feasibility of using a self-report geriatric assessment tool in this population

Enrollment: 17
Study Start Date: July 2004
Study Completion Date: July 2007
Detailed Description:

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.


Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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 80.
  Contacts and Locations
Please refer to this study by its identifier: NCT00215709

United States, Maryland
Baltimore, Maryland, United States, 21211
Sponsors and Collaborators
Geriatric Oncology Consortium
Principal Investigator: William Ershler, MD Geriatric Oncology Consortium
  More Information

Additional Information:
No publications provided Identifier: NCT00215709     History of Changes
Other Study ID Numbers: GOC GU-010
Study First Received: September 19, 2005
Last Updated: November 15, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Geriatric Oncology Consortium:

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014