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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is studying how well cediranib maleate works in treating patients with recurrent or newly diagnosed metastatic head and neck cancer. Cediranib maleate may stop the growth of head and neck cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cediranib; Maleic acid

Criteria

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