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

Geriatric Oncology Consortium

Status and phase

Completed

Phase 1

Conditions

Prostate Cancer

Treatments

Drug: docetaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00215709

GOC GU-010

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

Male

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.