A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients

Inclusion Criteria

• •Patient who had histologically confirmed adenocarcinoma of the prostate.
• •Patient must have radiologically documented metastatic disease.
• •Patients should have received at least 12 weeks of docetaxel chemotherapy or a cumulative docetaxel dose of 300 mg/m2 and have disease progression on docetaxel-based therapy. Patients must have progressed after prior hormonal therapy (e.g. medical or surgical castration) as defined by a castrate level of testosterone (less than 50 ng/mL). If patient underwent medical castration, it must be continued during the study.
• •Progressive disease may be documented by:
• •* Non-measurable disease:
• •* Serum PSA progression defined as a rise in at least 2 consecutive serum PSA values, each obtained at least 1 week apart and an absolute value greater than 2.0 ng/ml or,
• •* Appearance of two or more new lesions on bone scan.
• •* Patients with treated epidural lesions and no other epidural progression will be eligible.
• •* Measurable disease
• •* Documented progression of disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria demonstrating at least one visceral or soft tissue metastatic lesion (including new lesion).
• •* Nodal or visceral progression will be sufficient for trial entry independent of PSA
• •* Only lymph nodes ≥ 2 cm in diameter will be used to assess for a change in size.
• •* Previously irradiated lesions, primary prostatic lesion, and bone lesions will be considered non-measurable disease.
• •Patient is 18 years or older.
• •Patient had a Karnofsky Performance Status (KPS) of at least 70% or Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.
• •Life expectancy of \> 6 months.
• •Patient with adequate organ function as defined as
• •* Absolute Neutrophils Count greater than 1500 cells/mm3
• •* Platelets greater than 100,000 cells/mm3
• •* Hemoglobin greater than 8 g/dL,
• •* Adequate liver function as documented by:
• •* Total Bilirubin \</= 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
• •* AST and ALT \</= 2.5 ULN. (In determining eligibility the more abnormal of the two values (AST or ALT) should be used.)
• •* Serum creatinine \</= 2.0 mg/dl or \</= 1.5 x institutional upper limit of normal.
• •Male patient must be willing to use an acceptable barrier method for contraception; and must agree not to father a child whilst receiving treatment with Azacitidine and up to six months after last dose.
• •Patients may have a history of prior malignancy (≥ 5 years prior) provided that the patient is currently disease free and off all therapy for that malignancy. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
• •Patients must be informed of the investigational nature of the treatment and must give signed written and informed consent.