Cixutumumab and Temsirolimus in Treating Patients With Metastatic Prostate Cancer

Inclusion Criteria

• •Histologically or cytologically confirmed adenocarcinoma of the prostate
• •* Distant metastases evaluable by radionuclide bone scan, CT scan, or magnetic resonance imaging (MRI) within the past 28 days
• •Evidence of progressive disease during androgen-deprivation therapy (including a trial of antiandrogen-withdrawal therapy), as defined by ≥ 1 of the following criteria:
• •* Progressive measurable disease using conventional solid tumor criteria
• •* Bone scan progression, defined as ≥ 2 new lesions on bone scan
• •* Increasing PSA, defined as ≥ 2 consecutive rising PSA values over a reference value taken ≥ 1 week apart (the third PSA value must be greater than the second PSA value, if not, a fourth PSA value must be greater than the second PSA value)
• •Castrate levels of serum testosterone (i.e., ≤ 50 ng/dL)
• •No known brain metastases
• •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100%
• •Life expectancy \> 6 months
• •Leukocytes ≥ 3,000/μL
• •Absolute neutrophil count (ANC) ≥ 1,500/μL
• •Platelet count ≥ 100,000/μL
• •Hemoglobin ≥ 9 g/dL
• •Total bilirubin ≤ 2 times upper limit of normal (ULN)
• •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN
• •Serum creatinine ≤ 1.5 times ULN
• •Creatinine clearance ≥ 50 mL/min
• •Able to adhere to the study visit schedule and other study requirements
• •Fertile patients must use effective contraception before, during, and for 3 months after completion of study treatment
• •Adequate lung function (pulmonary function test ≥ 70% for diffusion capacity of the lung for carbon monoxide \[DLco\])
• •No poorly controlled diabetes mellitus
• •* Patients with a history of diabetes are eligible provided their blood glucose is normal (i.e., fasting blood glucose \< 120 mg/dL or \< ULN) and they are on a stable dietary or therapeutic regimen
• •No other malignancy within the past 3 years except for treated basal cell or squamous cell carcinoma of the skin or superficial transitional cell carcinoma of the bladder
• •No uncontrolled major illness including, but not limited to, any of the following:
• •* Active infection, including human immunodeficiency virus (HIV) infection or viral hepatitis
• •* Symptomatic congestive heart failure (class III or IV)
• •* Unstable angina pectoris
• •* Myocardial infarction or acute coronary syndrome within the past year
• •* Serious cardiac arrhythmia
• •* Significant lung disease
• •* Major psychiatric illness
• •No other concurrent anticancer agents or treatments
• •No prior chemotherapy, except for neoadjuvant chemotherapy
• •No prior anti-insulin-like growth factor receptor (IGFR) agents or mammalian target of rapamycin (mTOR) inhibitors
• •No prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy
• •Prior standard-dose radiotherapy to the pelvis for prostate cancer and/or additional external-beam radiotherapy to metastatic sites allowed
• •More than 4 weeks since prior surgery, radiotherapy, combined androgen blockade (excluding single-agent gonadotropin releasing-hormone agonists/antagonists), or investigational therapies
• •No concurrent second-line hormonal agents, including ketoconazole, diethylstilbestrol, other estrogen-like agents, or finasteride
• •No concurrent corticosteroids unless patient is on a stable maintenance dose of hydrocortisone (≤ 30 mg/day) for ≥ 3 months