Mode
Text Size
Log in / Sign up
Phase 2 N=25 Treatment

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

Esophageal Cancer

Enrolled (actual)
25
Serious AEs
100.0%
Results posted
Mar 2017
Primary outcome: Primary: Progression-free Survival Rate — 7 weeks

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
sunitinib malate (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Tony Bekaii-Saab
Primary completion
Sep 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-free Survival Rate
7
SECONDARY
Overall Response Rate
10
SECONDARY
Median Overall Survival Time
16.6
SECONDARY
Median Progression-free Survival Time
6.9
SECONDARY
Frequency and Severity of Adverse Events
52; 24; 0; 48; 12; 8
SECONDARY
Change in Mean Vessel Density
SECONDARY
Quantitative Assessment of Proliferating Tumor Cells and Apoptosis

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00702884). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search