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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Geriatric Oncology Consortium
ClinicalTrials.gov Identifier:
NCT00215709
First received: September 19, 2005
Last updated: November 15, 2007
Last verified: November 2007
  Purpose

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.

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215709

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

Additional Information:
No publications provided

ClinicalTrials.gov 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:
elderly

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014