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

• Status: Completed
• Trial end date: 2013-12-30
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Tony Bekaii-Saab
• Collaborator: Pfizer
• Treatments: Sunitinib

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)