Pazopanib Hydrochloride With or Without Bicalutamide in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

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

Inclusion Criteria:

• Histologically or cytologically confirmed prostate cancer

• Must have received prior hormonal therapy, including either medical (luteinizing hormone-releasing hormone [LHRH] agonist) or surgical (orchiectomy) castration

  • Castrate level of testosterone (< 50 ng/dL)
  • Patients treated with LHRH agonists must continue or restart this therapy
• Must have radiological documentation of either measurable or non-measurable disease

• Must show documented progression of prostate cancer while on hormonal therapy as indicated by PSA increase

  • Rising PSA is defined as ≤ 2 consecutive rises in PSA taken ≥ 1 week and ≤ 2 months apart
• PSA >= 5 ng/mL
• No known brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy > 3 months
• White blood cell (WBC) >= 3,000/mm^3
• Absolute neutrophil count (ANC) >= 1,500/mm^3
• Platelet count >= 100,000/mm^3
• International normalized ratio (INR) =< 1.2
• Activated partial thromboplastin time (PTT) =< 1.2 times upper limit of normal (ULN)
• Bilirubin normal
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 times ULN
• Creatinine normal OR creatinine clearance >= 60 mL/min
• Fertile patients must use effective contraception
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or bicalutamide
• Proteinuria =< 1+ on 2 consecutive dipsticks taken >= 1 week apart
• QTc < 480 msec
• No significant electrocardiogram (ECG) abnormalities
• No poorly controlled hypertension (systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 90 mm Hg)
• No condition (e.g., gastrointestinal [GI] tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation; prior surgical procedures affecting absorption; or active peptic ulcer disease) that impairs the ability to swallow and retain pazopanib hydrochloride tablets
• No serious or nonhealing wound, ulcer, or bone fracture
• No abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within the past 28 days
• No cerebrovascular accident within the past 6 months
• No myocardial infarction, cardiac arrhythmia, admission for unstable angina, cardiac angioplasty, or stenting within the past 12 weeks
• No venous thrombosis within the past 12 weeks

• No New York Heart Association (NYHA) class III-IV heart failure

  • Patients with a history of NYHA class II heart failure who are asymptomatic on treatment are eligible
• No concurrent uncontrolled illness, including, but not limited to, ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• Recovered from all prior therapy
• Prior neoadjuvant or adjuvant chemotherapy allowed
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy
• At least 4 weeks since prior antiandrogens
• At least 4 weeks since prior surgery
• No prior bicalutamide therapy lasting > 3 months in duration
• Concurrent steroids allowed if no change in steroid dosage within the past 4 weeks
• No other concurrent investigational agents

• No concurrent therapeutic warfarin

  • Concurrent low molecular weight heparin or prophylactic low-dose warfarin allowed
• No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients