LCI-GU-BLA-SPEC-001: Aurora Kinase Expression in Muscle-Invasive Bladder Cancer

• Histologically confirmed American Joint Committee on Cancer seventh edition clinical stage T2-4a N0-3 urothelial carcinoma of the bladder based on diagnostic transurethral bladder biopsy or transurethral resection of bladder tumor (TURBT) confirming the presence of urothelial carcinoma with muscularis propria invasion.
• Archived tissue from prior biopsy/resection must be available for baseline AK analysis.
• Subjects must be eligible to undergo radical cystectomy and cisplatin-based chemotherapy.
• Subjects with radiographically enlarged lymph nodes (short axis >10 mm with CT scan or MRI) should undergo percutaneous biopsy for staging in accordance with local practices, though preferred, is not mandatory for study enrollment.
• A baseline computed tomography (CT) scan with intravenous contrast of the chest, abdomen and pelvis is required in all subjects. A radionuclide bone scan is also required in subjects with skeletal pain or abnormally elevated alkaline phosphatase values.
• Age at least 18 years old.
• ECOG performance status of 0 or 1.
• Bilirubin less than 1.5 mg/dL.
• Subjects must have adequate liver function: AST and ALT less than 2.5x upper limit of normal, alkaline phosphatase less than 2.5x upper limit of normal.
• Subjects must have adequate bone marrow function: Platelets greater than 100,000 cells/mm3, Hemoglobin greater than 9.0g/dL and ANC greater than 1,500 cells/mm3.
• Subjects must have adequate renal function with creatinine clearance of at least 60 mL/min.
• Subjects must sign a written informed consent document and authorization for release of their medical records for the purposes of research.

Exclusion Criteria

• Pure non-urothelial or mixed small cell histology identified within TURBT specimen.
• Absence of documented urothelial carcinoma with muscularis propria invasion on diagnostic transurethral bladder biopsy or transurethral resection of bladder tumor (TURBT).
• Distant metastatic disease, including non-regional lymphadenopathy and visceral metastases, identified on pretreatment radiographic studies.
• Creatinine clearance less than 60 mL/min.
• CTCAE version 4 grade 2 or greater hearing loss.
• CTCAE version 4 grade 2 or greater peripheral neuropathy.
• NYHA class III heart failure or cardiac ejection fraction less than or equal to 50%.
• Women of child-bearing age who are pregnant or breast feeding.
• Uncontrolled and current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Subjects with other active malignancies as defined as synchronous malignancy at the time of bladder cancer diagnosis, excluding non-metastatic, non-melanoma skin cancer are excluded.
• Major surgery within 4 weeks of consent.
• Subjects requiring therapeutic anticoagulation at the time of consent.
• Currently enrolled on another clinical trial for the treatment of bladder cancer.