Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel

This is an interventional supportive care trial for Diarrhea Read More

Inclusion Criteria:

• Histologically or cytologically confirmed prostate cancer
• Measurable disease on computed tomography (CT) or evaluable disease with an elevated PSA
• Documented progression on (a) at least one prior hormone treatment, which must have incorporated luteinizing hormone-releasing hormone (LHRH) agonist therapy AND (b) at least one chemotherapy regimen, which must have included docetaxel; progression may be demonstrated by radiologic criteria or by PSA only if accompanied by new or worsening symptoms (pain progression)
• Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
• Absolute neutrophil count (ANC) more than or equal to 1500/ul
• Hemoglobin more than or equal to 8.0 g/dL
• Platelet count more than or equal to 100,000/ul
• Serum creatinine less than or equal to 1.5x the upper limit of normal (ULN)
• Bilirubin less than or equal to ULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 1.5x ULN
• Must be recovered from acute and late effects of any prior surgery, radiotherapy or other anti-neoplastic therapy
• Patients or their legal representatives must be able to read, understand, and provide informed consent
• Men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter
• Palliative radiation for metastatic disease is allowed if less or equal to 40% of the total bone marrow was irradiated; 28 days must have elapsed since completion of radiation therapy (RT) with bone marrow recovery; soft tissue disease irradiated in the prior 2 months may not be designated as measurable disease
• Concomitant bisphosphonate use is permitted if the dose had been stable for 12 weeks prior to enrollment

Exclusion Criteria:

• Treatment with radiotherapy, chemotherapy or any investigational agent in the prior 4 weeks
• Major surgery in the prior 4 weeks
• Prior treatment with cabazitaxel
• Patients with known hypersensitivity to cabazitaxel, other drugs formulated with polysorbate 80 or octreotide
• Inability to tolerate oral prednisone
• Grade 2 or greater diarrhea in the prior 2 weeks
• Grade 2 or greater neuropathy or stomatitis
• Presence of an active uncontrolled infection or fever greater or equal to 38.5 degrees
• Presence of parenchymal brain metastases; patients with neurological symptoms must have a CT or magnetic resonance imaging (MRI) of the brain showing no metastases within 60 days of enrollment
• Prior malignancy within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder or other stage I or stage II cancer in complete remission for at least 12 months
• History of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or congestive heart failure (CHF) or recent myocardial infarction (MI)within 6 months of enrollment
• Known human immunodeficiency virus (HIV) or hepatitis infection
• Life expectancy less than 3 months
• Presence of any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with interpretation of the results
• Lack of ability/willingness to give informed consent
• Lack of ability/willingness to receive octreotide injection
• Anticipated non-availability for study visits/procedures
• Patients with uncontrolled diabetes, defined as a HbA1c greater than 7% or greater or equal to 8% despite therapy, or a fasting plasma glucose more than 2x ULN; at the investigator's discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted