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

Inclusion Criteria:

* 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