Status:
COMPLETED
A Study of Sunitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands
Lead Sponsor:
University Health Network, Toronto
Conditions:
Adenoid Cystic Carcinoma
Salivary Gland Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II study to evaluate the effectiveness of study drug sunitinib malate in patients with recurrent and/or metastatic adenoid cystic carcinomas of the salivary gland. There currently is n...
Detailed Description
This is an open-label phase II study of sunitinib malate in patients with recurrent and/or metastatic adenoid cystic carcinomas (ACC) of major or minor salivary gland origin. Sunitinib is a novel, mul...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00886132
Start Date
January 1 2007
End Date
December 1 2012
Last Update
July 23 2015
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9