A Phase 2 Study of Sunitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands
- Patients must have histologic or cytologic adenoid cystic carcinomas of major or
minor salivary gland origin.
- Patients must have recurrent and/or metastatic disease that is progressive and not
amenable to surgery or curative radiotherapy occurring within 6 months of study
- at least a 20% increase in radiologically or clinically measurable disease;
- appearance of any new lesions or
- deterioration in clinical status
- Patients must have measurable disease, at least one lesion that can be accurately
measured in at least one dimension as >20 mm with conventional techniques or as >10
mm with spiral CT scan.
- Patients with prior therapy with at least a 4 weeks' interval between any
chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy or surgery and
study enrollment. Exceptions may be made for low dose, non-myelosuppressive
- Patients must be 18 years of age or older.
- Life expectancy of greater than 12 weeks.
- Patients must have normal organ and marrow function as defined below:
- leukocytes >3,000/μL
- absolute neutrophil count >1,500/μL
- platelets >100,000/μL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
- amylase/lipase within normal institutional limits
- creatinine within normal institutional limits
- creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels
above institutional normal
- Cardiac ejection fraction within the institutional range of normal as measured by
ECHO or MUGA scan.
- Patients must have QTc < 500 msec on baseline ECG.
- Patients with New York Heart Association (NYHA) Class II cardiac function:
- with a history of Class II heart failure who are asymptomatic on treatment
- with prior anthracycline exposure
- who have received central thoracic radiation that included the heart in the
- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control or abstinence) prior to study entry and
for the duration of study participation.
- Ability to understand and the willingness to sign a written informed consent
- 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
- 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
- Pregnant women. Breastfeeding should be discontinued if the mother is treated with
- 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.