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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00215709
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 19, 2007
Information provided by:
Geriatric Oncology Consortium

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: docetaxel Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : July 2004
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Primary Outcome Measures :
  1. 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 :
  1. To determine the dose limiting toxicity effects and other toxic effects of this regimen
  2. To determine the activity of this regimen in terms of: Overall response rates; Pain scores and analgesic use; PSA response rates;
  3. To evaluate the feasibility of using a self-report geriatric assessment tool in this population

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00215709

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United States, Maryland
Baltimore, Maryland, United States, 21211
Sponsors and Collaborators
Geriatric Oncology Consortium
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Principal Investigator: William Ershler, MD Geriatric Oncology Consortium
Layout table for additonal information Identifier: NCT00215709    
Other Study ID Numbers: GOC GU-010
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 19, 2007
Last Verified: November 2007
Keywords provided by Geriatric Oncology Consortium:
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action