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

Phase 1

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00215709
• Lead Sponsor: Geriatric Oncology Consortium

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-22
• Study Completion: 2007-07
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-15
• Last Update Posted: 2007-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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