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

This is an interventional treatment trial for Esophageal Cancer focused on measuring recurrent esophageal cancer, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer, stage IV esophageal cancer Read More

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)