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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Geriatric Oncology Consortium
• Collaborator: Sanofi
• Treatments: Docetaxel; Hormones

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.