Saracatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
• Persistent, recurrent, or metastatic disease that is not amenable to curative-intent therapy with surgery or radiation
• Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral computed tomography (CT) scan
• Karnofsky performance status ≥ 60%
• White blood cell (WBC) ≥ 3,000/mcL
• Absolute neutrophil count ≥ 1,500/mcL
• Platelets ≥ 100,000/mcL
• Hemoglobin > 9 g/dL
• Total bilirubin within upper institutional limits of normal (ULN)
• Aspartate aminotransferase (AST) /alanine aminotransferase (ALT) ≤ 2.5 x ULN
• Creatinine within ULN OR creatinine clearance ≥ 60 mL/min
• Patients must agree to use adequate birth control for the duration of study participation and for at least 8 weeks after discontinuation of study drug
• May have received 1 prior cytotoxic chemotherapy regimen for recurrent or metastatic disease

Exclusion Criteria

• Known brain metastases
• History of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
• Urine protein: creatinine ratio ≥ 1.0 OR 24-hour urine protein ≥ 1,000 mg
• QTc prolongation ≥ 480 msecs
• Intercurrent symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
• History of myocardial infarction within the past year
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or breastfeeding women
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy
• Pulmonary fibrosis ≥ grade 2, pleural effusion (non-malignant) ≥ grade 2, or pneumonitis/pulmonary infiltrates ≥ grade 2
• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
• Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Use of specifically prohibited cytochrome P450 3A4 (CYP3A4)-active agents or substances
• Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530
• Patients receiving any other investigational agents