Sunitinib in Treating Patients With Relapsed or Refractory Esophageal or Gastroesophageal Junction Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed esophageal or gastroesophageal junction carcinoma that is not amenable to curative surgery or other curative therapy
• •* Advanced, relapsed or refractory disease
• •Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
• •No known brain metastases
• •PATIENT CHARACTERISTICS:
• •ECOG (Eastern Cooperative Oncology Group) performance status 0-1
• •Life expectancy \> 12 weeks
• •WBC ≥ 3,000/μL
• •Absolute neutrophil count ≥ 1,500/μL
• •Platelet count ≥ 100,000/μL
• •Serum calcium ≤ 12.0 mg/dL
• •Total bilirubin normal
• •AST (aspartate aminotransferase) and ALT (Alanine Aminotransferase) ≤ 2.5 times upper limit of normal
• •Creatinine normal OR creatinine clearance ≥ 60 mL/min
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception prior to, during, and for 28 days after completion of study treatment
• •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate
• •No ongoing cardiac dysrhythmias ≥ grade 2, atrial fibrillation of any grade, or prolongation of the QTc (corrected QT interval) interval to \> 450 msec (for males) or \> 470 msec (for females)
• •No hypertension that cannot be controlled by medications (i.e., systolic/diastolic blood pressure \> 150/100 mm Hg despite optimal medical therapy)
• •No myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within the past 12 months
• •No cerebrovascular accident or transient ischemic attack within the past 12 months
• •No pulmonary embolism within the past 12 months
• •No condition that would impair the ability to swallow and retain sunitinib malate tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease)
• •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
• •No serious or nonhealing wound, ulcer, or bone fracture
• •No pre-existing thyroid abnormality that cannot be maintained in the normal range with medication
• •No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situation that would limit compliance with study requirements
• •PRIOR CONCURRENT THERAPY:
• •Recovered from prior therapy
• •At least 4 weeks since prior radiotherapy or major surgery
• •At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C, carmustine, or alkylating agents)
• •No more than 6 prior courses of an alkylating agent
• •No more than 450 mg/m² of prior doxorubicin hydrochloride or 900 mg/m² of prior epirubicin hydrochloride
• •No more than 2 lines of prior therapy in the metastatic setting
• •No prior anti-VEGF monoclonal antibodies, such as bevacizumab or aflibercept
• •No prior tyrosine kinase inhibitors with similar targets (e.g., sorafenib tosylate or axitinib)
• •No other concurrent investigational agents
• •No concurrent therapeutic doses of coumarin-derivative anticoagulants, such as warfarin
• •* Warfarin at doses of ≤ 2 mg daily are allowed for prophylaxis of thrombosis
• •* Low molecular weight heparin allowed provided PT/INR (Prothrombin time and international normalized ratio) is ≤ 1.5
• •No concurrent combination antiretroviral therapy for HIV-positive patients
• •No concurrent agents with proarrhythmic potential (e.g., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide)