Status:
COMPLETED
Sunitinib in Treating Patients With Relapsed or Refractory Esophageal or Gastroesophageal Junction Cancer
Lead Sponsor:
Tony Bekaii-Saab
Collaborating Sponsors:
Pfizer
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 we...
Detailed Description
OBJECTIVES: Primary * To determine the progression-free survival rate (complete response, partial response, and stable disease as defined by RECIST criteria \[Response Evaluation Criteria in solid T...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
June 30 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00702884
Start Date
June 30 2008
End Date
December 30 2013
Last Update
March 21 2017
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210