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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-07-31

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.

Conditions

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Prostate Cancer

Keywords

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elderly

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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docetaxel

Intervention Type DRUG

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.

Minimum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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William Ershler, MD

Role: PRINCIPAL_INVESTIGATOR

Geriatric Oncology Consortium

Locations

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Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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GOC GU-010

Identifier Type: -

Identifier Source: org_study_id