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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study of Docetaxel on a Bi-Weekly Schedule in the Treatment of Elderly Men With Hormone-Refractory Prostate Cancer (HRPC)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly