Sunitinib in Treating Patients With Relapsed or Refractory Esophageal or Gastroesophageal Junction Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: sunitinib malate
Intervention description: Sunitinib 37.5 mg daily for a 4 week cycle
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent esophageal cancer; stage IIIA esophageal cancer; stage IIIB esophageal cancer; stage IIIC esophageal cancer; stage IV esophageal cancer

Summary:

      RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with
      relapsed or refractory esophageal or gastroesophageal junction cancer.
    

Eligibility 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)