Cediranib Maleate in Treating Patients With Recurrent or Newly Diagnosed Metastatic Head and Neck Cancer

You may be eligible if

• Histologically confirmed squamous cell carcinoma of the head and neck meeting one of the following criteria:
• * Recurrent disease
• * Previously treated with standard curative therapy, including surgery and/or radiotherapy with or without chemotherapy
• * Newly diagnosed metastatic disease
• Must be deemed incurable by all of the following:
• * Salvage surgery
• * Radiotherapy
• Measurable disease ≥ 1 cm by conventional techniques, flexible fiberoptic laryngoscopy, or examination under anesthesia
• No more than 2 prior conventional or investigational systemic therapies for categorically incurable local-regional or distant disease
• No known primary brain tumor or brain metastases
• ECOG performance status 0-1
• Life expectancy ≥ 6 months
• WBC \> 3,000/mm³
• Absolute neutrophil count \> 1,500/mm³
• Platelet count \> 100,000/mm³
• Hemoglobin \> 8 g/dL
• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal
• Creatinine normal OR creatinine clearance \> 60 mL/min
• Proteinuria ≤ +1 on 2 consecutive urine dipsticks taken ≥ 1 week apart
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• History of nonmelanoma skin cancer or other prior malignancy allowed provided the cancer has been in remission for \> 3 years
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to AZD2171
• No hypertension (i.e., systolic blood pressure (BP) \> 160 mm Hg and diastolic BP \> 100 mm Hg)
• No history of hypertensive urgency, hypertensive emergency, or end-organ damage (i.e., thrombotic stroke, transient ischemic attacks, intracerebral hemorrhage, myocardial infarction, aortic aneurysm, or aortic dissection)
• QTc ≤ 500 msec (with Bazett's correction)
• No history of familial long QT syndrome
• No concurrent uncontrolled illness including, but not limited to, any of the following:
• * Bleeding diathesis
• * Congestive heart failure, defined as New York Heart Association (NYHA) class III-IV congestive heart failure
• * NYHA class II congestive heart failure allowed provided there is increased monitoring
• * Significant ECG abnormality
• * Peripheral vascular disease
• * Unstable angina pectoris
• * Cardiac arrhythmia
• * Pulmonary edema
• * Atrioventricular (AV) conduction abnormalities
• * Sick sinus syndrome
• * Second- or third-degree AV block
• * Deep venous thrombosis
• No nonhealing ulcers, bone fracture, or wounds
• No psychiatric illness or social situation that would preclude study compliance
• No traumatic injury within the past 7 days
• No known coagulopathy that increases risk of bleeding
• No history of clinically significant hemorrhages
• See Disease Characteristics
• Recovered from all prior therapies
• No prior antiangiogenic therapy
• No more than 2 prior chemotherapy or antineoplastic regimens for categorically incurable local-regional or distant disease
• At least 4 weeks since prior radiotherapy or major surgery
• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
• More than 30 days since prior participation in an investigational trial
• No other concurrent investigational agents
• No concurrent drugs or biologics with proarrhythmic potential
• No concurrent anticoagulants (e.g., warfarin) or antiplatelet agents
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent anticancer agents or therapies