Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma

Exclusion Criteria

• •History of other malignancies.
• •Patients with known brain metastases.
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib.
• •Patients receiving concurrent treatment with other anti-cancer therapy given for paraganglioma or pheochromocytoma or other therapy or other investigational anticancer agents.
• •Patients who have received prior treatment with any other antiangiogenic agent or multi-targeted tyrosine kinase inhibitors are ineligible.
• •Patients with any of the following cardiovascular findings are to be excluded:
• •QTc prolongation or other significant ECG abnormalities.
• •Current or history of Class III or IV heart failure as defined by the NYHA functional classification system
• •Patients with prior anthracycline exposure, previous central thoracic radiation that included heart in radiation port, or a history of NYHA Class II cardiac function.
• •Poorly controlled hypertension
• •Myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry
• •History of venous thrombosis or pulmonary embolism in the past 3 months
• •History of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry
• •Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin
• •Patients with bowel obstruction or any condition that impairs their ability to swallow and retain sunitinib tablets.
• •Use of agents with proarrhythmic potential is not permitted during the study.
• •Must be able to stop prohibited selected CYP3A4 inhibitors/inducers prior to starting sunitinib
• •Patients with pre-existing hypothyroidism prior to enrolment are ineligible unless they are euthyroid on medication.
• •Pregnant or lactating women, positive pregnancy test, women of childbearing potential who do not agree to use adequate contraception prior to study entry and for the duration of study participation.
• •Known HIV-positive patients on combination antiretroviral therapy
• •Greater than +1 proteinuria on urinary dipstick if also \>1g urinary protein/24hrs