Bi-Weekly Administration of Docetaxel for Older Men With Hormone Refractory Prostate Cancer
This study has been completed.
Information provided by:
Geriatric Oncology Consortium
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.
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Pilot Study of Docetaxel on a Bi-Weekly Schedule in the Treatment of Elderly Men With Hormone-Refractory Prostate Cancer (HRPC)
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
| Study Start Date:
| Study Completion Date:
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:
|Accepts Healthy Volunteers:
- 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.
- 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.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215709
|Baltimore, Maryland, United States, 21211 |
Geriatric Oncology Consortium
||William Ershler, MD
||Geriatric Oncology Consortium
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 19, 2005
||November 15, 2007
||United States: Institutional Review Board
Keywords provided by Geriatric Oncology Consortium:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Molecular Mechanisms of Pharmacological Action