| Exclusion Criteria: | 1) Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
2) At least 4 weeks must have elapsed since any major surgery.
3) Patients may not be receiving any other investigational agents
4) Patients who have received prior treatment with any other antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, PTK787, VEGF Trap, etc.).
5) History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib.
6) Patients with QTc prolongation (defined as a QTc interval equal to or greater than 500 msec), serious ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia greater than or equal to 3 beats in a row) or other significant ECG abnormalities are excluded.
7) Patients with poorly controlled hypertension (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher) are ineligible.
8) Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis. Note: Low molecular weight heparin is permitted provided the patient's PT INR is </=1.5.
9) Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain sunitinib tablets are excluded.
10) Patients with any of the following conditions are excluded: • Serious or non-healing wound, non-healing ulcer, or non-healing bone fracture. • History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 28 days of treatment. • Any history of CVA or TIA within 12 months prior to study entry. classification system months prior to study entry. • History of pulmonary embolism within the past 12 months. • Class III or IV heart failure as defined by the NYHA functional classification system.
11) Continued from # 10 History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within past 12 months • History of pulmonary embolism within the past 12 months. • Class III or IV heart failure as defined by the NYHA functional
12) Sunitinib is metabolized primarily by the CYP3A4 liver enzyme, the eligibility of patients taking medications that are potent inducers or inhibitors of that enzyme will be determined following a review of their case by the Principal Investigator. Every effort should be made to switch patients taking such agents or substances to other medications, particularly patients with gliomas or brain metastases who are taking enzyme-inducing anticonvulsant agents. A comprehensive list of medications and substances known or with the potential to alter the pharmacokinetics of sunitinib through CYP3A4.
13) Patients with known brain mets should be excluded because of poor prognosis & because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic & other adverse events. Patients with treated brain metastases 8 weeks out of therapy are allowed. Patients can't be receiving enzyme inducing anti-convulsants including carbamazepine, phenobarbital, and phenytoin.
14) Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements are ineligible.
15) Pregnant women are excluded from this study because sunitinib is an antiangiogenic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib, breastfeeding should be discontinued if the mother is treated with sunitinib malate.
16) HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sunitinib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
17) Patients with conditions classified as NYHA III or IV per the New York Heart Association Classifications
18) Patients with an ejection fraction of < 40% |