Cixutumumab and Temsirolimus in Treating Patients With Metastatic Prostate Cancer

This is an interventional treatment trial for Hormone-Resistant Prostate Cancer Read More

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