Temsirolimus and Bevacizumab in Hormone-Resistant Metastatic Prostate Cancer That Did Not Respond to Chemotherapy

Inclusion

• Understand and voluntarily sign an informed consent form
• Patients with histologically confirmed adenocarcinoma of the prostate
• Patients must have evidence of chemotherapy-refractory metastatic CRPC following standard antiandrogen withdrawal (AAWD); CRPC will be defined as patients with metastatic prostate cancer with radiologic evidence of metastases on either bone scan, plain x-rays, CT scans, chest x-ray, and castrate levels of testosterone ( = = 1500/uL
• Hemoglobin >= 8 g/dL (blood transfusion not permitted within 2 weeks prior to first dose of treatment)
• Platelets >= 100,000/uL
• Serum creatinine = = 150 mmHg systolic and/or >= 100 mmHg diastolic on medication), or any prior history of hypertensive crisis or hypertensive encephalopathy
• History of stroke or transient ischemic attack within 6 months prior to screening
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection), or symptomatic peripheral vascular disease
• Known congenital long QT syndrome, history of Torsade de pointes or ventricular tachycardia
• Known pulmonary hypertension or pneumonitis
• More than 1 episode of DVT/PE within the last 6 months
• Evidence or history of bleeding diathesis or coagulopathy
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to screening
• Supplements or complementary medicines/botanicals are not permitted while on protocol therapy, except for any combination of the following: conventional multivitamin supplements; selenium; lycopene; soy supplements; patients should review the label with their doctor prior to enrollment, and discontinue disallowed agents prior to study enrollment; patients taking St. John's Wort need to discontinue its use at least 7 days prior to initiating trial
• Serious intercurrent infections or non-malignant medical illnesses including uncontrolled autoimmune disorders
• Psychiatric illnesses/social situations that would limit compliance with protocol requirements
• Known contraindication to receive temsirolimus or AVASTIN
• Use of any other experimental drug or therapy within 28 days of baseline
• Immunocompromised subjects, including known seropositivity for human immunodeficiency virus (HIV), or current or chronic hepatitis B and/or hepatitis C infection (as detected by positive testing for hepatitis B surface antigen [HbsAg] or antibody to hepatitis C virus [anti HCV] with confirmatory testing) (testing is not mandatory to be eligible for the study)
• Anticancer therapies such as biologic therapy and chemotherapy, as well as radiation therapy or cancer surgery
• Other current or recent (within 4 weeks prior to randomization) investigational agent
• Rifampicin
• Immunosuppressive therapies except steroids
• Prophylactic use of white blood growth factors to support neutrophils
• Concomitant treatment with agents that have CYP3A4 induction or inhibition potential should be voided