safety and efficacy study of pertuzumab to treat castration-resistant prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate safety and efficacy of omnitarg (pertuzumab) on cancerous lesions in men with castration-resistant (hormone-refractory) prostate cancer.


Eligibility criteria:
inclusion criteria: * signed informed consent * age \>= 18 years old * histologically documented adenocarcinoma of the prostate, clinically refractory or resistant to hormone therapy, as assessed by progression following at least one hormonal therapy (orchiectomy or luteinizing hormone-releasing hormone \[lhrh\] agonist). subjects must have documented progression following hormonal therapy withdrawal of \>= 4 weeks duration; nilutamide and bicalutamide require 6 weeks withdrawal. * progression of disease after one prior chemotherapy regimen (which must have been taxane-based) for crpc. progression is defined as at least one of the following: a minimum of three consecutive serum psa measurements obtained \>= 14 days apart and all within 3 months, with progressively increasing values for two consecutive measurements. the latest value must be obtained within the screening period and must be \>= 5 ng/ml; or progression of measurable disease, as defined by recist; or progression of bone disease, as defined by the appearance of one or more new bone lesions * orchiectomy, or castrate levels of testosterone maintained by lhrh agonist \<70 ng/ml * life expectancy \>= 12 weeks * ecog performance status of 0 or 1 * granulocyte count of \>= 1500/ml, platelet count of \>= 75,000/ml and hemoglobin of \>= 9 g/dl (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbopoeitin \[aranesp\] is permitted) * serum bilirubin less than or equal to the upper limit of normal (uln), unless due to gilbert's disease, and alkaline phosphatase, ast, and alt \<= 2.5 x uln (alt, ast, and alkaline phosphatase \<= 5 x uln for subjects with liver metastases; no alkaline phosphatase upper limit for subjects with bone metastases) * serum creatinine \<= 1.5 x uln * international normalized ratio (inr) \<1.5 and activated partial thromboplastin time (aptt) \<1.5 x uln (except for subjects receiving warfarin) * willing to complete serial prosqoli/ppi evaluations and serial diaries of analgesic use (if necessary) exclusion criteria: * prior chemotherapy, radiotherapy, therapeutic radionucleotide or immunotherapy within 4 weeks of day 1 (the day of the first rhumab 2c4 dose). flutamide therapy, or other second line hormonal therapies should be withdrawn \>= 4 weeks prior to day 1. bicalutamide and nilutamide therapy should be withdrawn \>= 6 weeks prior to starting study medication. * prior treatment with her2 pathway inhibitors (e.g., herceptin \[trastuzumab\], iressa \[gefitinib\], tarceva \[erlotinib hydrochloride\], c225, ci1033, and tak165) * treatment with other experimental anticancer agents within 4 weeks prior to day 1 * prior history or clinical evidence of central nervous system or brain metastases * ejection fraction, determined by echo, \<50% * uncontrolled hypercalcemia (\>11.5 mg/dl) * prior exposure of \>360 mg/m2 doxorubicin, \>120 mg/m2 mitoxantrone, or \>90 mg/m2 idarubicin * ongoing corticosteroid treatment, except for subjects who are on stable doses of \<20 mg of prednisone daily (or equivalent), or who are taking corticosteroids for reasons unrelated to prostate cancer * history of other malignancies within 5 years prior to day 1, except for adequately treated basal or squamous cell skin cancer * history of serious systemic disease, including active infection, uncontrolled hypertension (diastolic blood pressure \>100 mmhg on two consecutive occasions), unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to day 1, or unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation, paroxysmal supraventricular tachycardia, or controlled hypertension are eligible) * ongoing liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis * known human immunodeficiency virus infection * major surgery or significant traumatic injury within 3 weeks prior to day 1 * inability to comply with study and follow-up procedures * any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk for treatment complications