Tivozanib Before Surgery in Treating Patients With Localized Kidney Cancer

• Status: Withdrawn
• Trial end date: 2013-12-02
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial studies tivozanib before surgery in treating patients with localized kidney cancer. Tivozanib may stop the growth of tumor cells by blocking some of the growth factors needed for cell growth.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborators: AVEO Pharmaceuticals, Inc.; National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Biopsy proven non-metastatic clear cell RCC, as per radiographic studies is T2 - T3a based on the American Joint Committee on Cancer (AJCC) 6th edition criteria

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

• Hemoglobin >= 10 gm/dL

• Absolute neutrophil count (ANC) >= 1.5 X 10^9/L

• Platelets >= 100 X 10^9/L

• Total bilirubin < 1.5 X upper limit of normal (ULN)

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 X ULN

• International normalization ratio (INR) < 1.5

• Activated partial thromboplastin time (aPTT) < 1.2 X ULN

• Serum creatinine < 1.5 mg/dL or if >= 1.5 mg/dL: calculated creatinine clearance (CrCL) > 30 mL/min based on Cockroft-Gault formula

• Must have the ability to swallow and retain oral medication

• Patients of childbearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment

• Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

• Pregnant or nursing female patients

• Unwilling or unable to follow protocol requirements

• Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive tivozanib (solitary kidney, multiple tumors in the same or contralateral kidney)

• Not a candidate for surgery

• Received an investigational agent within 30 days prior to enrollment

• Non-clear cell or sarcomatoid histology

• Patients with metastatic disease at presentation

• Prior therapy with tyrosine kinase inhibitor for RCC

• A second primary malignancy (except squamous and basal cell carcinoma of skin) in the past 3 years

• Active or chronic infections

• Significant cardiovascular disease, including:

• Clinically symptomatic left ventricular failure

• Uncontrolled hypertension: systolic blood pressure of > 150 mmHg or diastolic blood pressure of > 100 mmHg documented on 2 consecutive measurements taken at least 24 hours apart

• Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of tivozanib

• History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)

• Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)

• Coronary or peripheral artery bypass graft within 6 months of screening

• History of coronary artery disease or peripheral arterial disease

• History of stroke or carotid endarterectomy

• Patients who are taking cytochrome P450 system (CYP)3A4 inducers are excluded; patients taking CYP3A4 inducers that can be safely replaced with another agent may be enrolled after a 5 day washout period