Carboplatin, Everolimus, and Prednisone in Treating Patients With Metastatic Prostate Cancer That Progressed After Docetaxel

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic adenocarcinoma of the prostate
• Objective disease progression or rising PSA despite androgen deprivation therapy and antiandrogen withdrawal (when applicable)
• Progressed after ≥ 1 prior docetaxel-based chemotherapy regimen for metastatic disease
• Patients with measurable disease* must have either rising PSA, increase in size of the lesion(s), or both
• Patients with rising PSA as the only evidence of disease progression must demonstrate a rising trend with 2 successive elevations ≥ 1 week apart
• Patients with no measurable disease must have a PSA ≥ 5 ng/mL or new areas of bony metastases on bone scan NOTE: *There is no minimum PSA requirement for patients with measurable disease
• Documented to be castrate with a testosterone level of ≤ 0.5 ng/mL
• Leuteinizing hormone-releasing hormone agonist therapy must be continued, if required to maintain castrate levels of testosterone
• No uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1
• ANC ≥ 1,500/mm^3
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 100,000/mm^3
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Calculated creatinine clearance ≥ 50 mL/min OR serum creatinine ≤ 2 mg/dL
• AST and/or ALT ≤ 2.5 times ULN if alkaline phosphatase normal OR alkaline phosphatase ≤ 4 times ULN if AST and/or ALT normal (for patients without documented bone metastases or for patients with liver metastases)
• AST and/or ALT 1.5 times ULN
• Liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
• Known history of HIV seropositivity, hepatitis B or C
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
• Active, bleeding diathesis
• No known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to their excipients
• No history of noncompliance to medical regimens
• No uncontrolled diabetes mellitus

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 1 prior docetaxel based regimen for metastatic disease
• Docetaxel based combination therapy or docetaxel alone considered as 1 regimen
• No more than 2 prior chemotherapy regimens for metastatic disease
• No prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus)
• At least 6 weeks since prior bicalutamide or nilutamide
• At least 4 weeks since prior flutamide
• More than 4 weeks since prior and no other concurrent investigational drugs
• More than 4 weeks since prior and no other concurrent anticancer therapies (including chemotherapy, radiotherapy, or antibody-based therapy)
• More than 4 weeks since prior and no concurrent major surgery (defined as requiring general anesthesia) and recovered
• More than 1 week since prior and no concurrent immunization with attenuated live vaccines
• No concurrent chronic, systemic treatment with corticosteroids or other immunosuppressive agents
• Topical or inhaled corticosteroids are allowed
• No concurrent prophylactic growth factors
• Concurrent bisphosphonate therapy allowed