A Study of Sunitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands

Exclusion Criteria

• •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. At least 4 weeks must have elapsed since any major surgery.
• •Patients receiving any other investigational agents.
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib.
• •Patients with QTc prolongation or other significant ECG abnormalities.
• •Patients with poorly controlled hypertension.
• •Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin, 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.
• •Patients with any condition that impairs their ability to swallow and retain sunitinib tablets.
• •Patients with any of the following conditions:
• •* Serious or non-healing wound, ulcer, or bone fracture.
• •* History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 28 days of treatment.
• •* Any history of cerebrovascular accident or transient ischemic attack within 12 months prior to study entry.
• •* History of 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 pulmonary embolism within the past 12 months.
• •* Class III or IV heart failure as defined by the NYHA.
• •Patients taking medications that are potent inducers or inhibitors of the CYP3A4 liver enzyme (unless deemed acceptable by the Principal Investigator).
• •Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication.
• •Patients with known brain metastases.
• •Patients with uncontrolled intercurrent illness including, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements.
• •Pregnant women. Breastfeeding should be discontinued if the mother is treated with sunitinib.
• •HIV-positive patients on combination antiretroviral therapy
• •Patients taking any of the medications that may cause QTc prolongation unless the required washout period has been met.