Abbreviations
CABA+pred+ADT
mitox+pred+ADT
378
377
Phase:
3
Open label
Prostate
mCRPC
meta
L2
- Histologically or cytologically confirmed adenocarcinoma of the prostate that is refractory to hormone therapy and previously treated with a Taxotere®-containing regimen. - Documented progression of disease (demonstrating at least one visceral or soft tissue metastatic lesion, including a new lesion). - Patients with non-measurable disease must have documented rising prostate-specific antigen (PSA) levels or appearance of new lesion. - Surgical or hormone-induced castration - Life expectancy > 2 months - ECOG performance status 0 - 2
- Previous treatment with mitoxantrone - Previous treatment with <225 mg/m^2 cumulative dose of Taxotere (or docetaxel) - Prior radiotherapy to ≥ 40% of bone marrow - Surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study - Other prior malignancy, except for adequately treated superficial basal cell skin cancer, or any other cancer from which the patient has been disease-free for less than 5 years - Known brain or leptomeningeal involvement - Other concurrent serious illness or medical conditions - Inadequate organ function evidenced by unacceptable laboratory results