Clinical Drug Experience Knowledgebase

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.