Expired Study
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Baltimore, Maryland 21211


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.


Study summary:

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.


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.


NCT ID:

NCT00215709


Primary Contact:

Principal Investigator
William Ershler, MD
Geriatric Oncology Consortium


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21211
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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