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

September 19, 2005
November 15, 2007
July 2004
Not Provided
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).
Same as current
Complete list of historical versions of study NCT00215709 on ClinicalTrials.gov Archive Site
  • 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
  • • 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
Not Provided
Not Provided
 
Bi-Weekly Administration of Docetaxel for Older Men With Hormone Refractory Prostate Cancer
A Pilot Study of Docetaxel on a Bi-Weekly Schedule in the Treatment of Elderly Men With Hormone-Refractory Prostate Cancer (HRPC)

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: docetaxel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
July 2007
Not Provided

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.
Male
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00215709
GOC GU-010
Not Provided
Not Provided
Geriatric Oncology Consortium
Sanofi
Principal Investigator: William Ershler, MD Geriatric Oncology Consortium
Geriatric Oncology Consortium
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP