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

This is an interventional treatment trial for Adenoid Cystic Carcinoma focused on measuring Phase 2 Study, Sunitinib, Recurrent, Metastatic, Adenoid Cystic Carcinoma, Salivary Glands, Metastasis Read More

Inclusion Criteria:

• 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 entry:

  • 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 radiotherapy.
• 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 radiotherapy port.
• 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 document.

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.