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Research and Clinical Trials

Title  
CTSU E2805: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
Brief Description  
This randomized phase III trial is studying sunitinib to see how well it works compared to sorafenib or placebo in treating patients with kidney cancer that has been removed by surgery.
Who may be Eligible  

  • Histologically or cytologically confirmed renal cell carcinoma, including any of the following subtypes:
    • Clear cell carcinoma
    • Nonclear cell carcinoma
  • Planning to start study treatment between 4-12 weeks after radical or partial nephrectomy
    • Underwent full surgical resection (i.e., radical or partial nephrectomy) by either open or laparoscopic technique within the past 3-10 weeks
      • Clinical evidence of lymph node positivity requires complete regional lymphadenectomy
      • All surgical specimens must have negative margins
    • Planning to undergo the above surgical resection AND meets all of the following criteria:
      • Primary intact renal cell carcinoma, eligible for nephrectomy with curative intent
      • Multifocal ipsilateral renal cell carcinoma allowed provided fully resectable and does not exceed inclusion criteria
  • No evidence of residual or metastatic renal cell cancer by scans/MRI
  • No history of distant metastases
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer, in situ cervical cancer, or ductal or lobular carcinoma in situ of the breast
  • No serious intercurrent illness, including, but not limited to, any of the following:
    • Clinically significant cardiovascular disease(e.g., uncontrolled hypertension, myocardial infraction, or unstable angina)
    • New York Heart Association class II-IV congestive heart failure
    • Peripheral vascular disease = grade 2
  • At least 6 months since any of the following:
    • Myocardial infarction
    • Severe or unstable angina
    • Coronary or peripheral artery bypass graft
    • Symptomatic congestive heart failure
    • Cerebrovascular accident
    • Transient ischemic attack
    • Pulmonary embolism
  • No ongoing ventricular cardiac dysrhythmias = grade 2
  • No ongoing atrial fibrillation
  • No history of serious ventricular arrhythmia
  • No uncontrolled hypertension (despite optimal medical therapy)
  • No pre-existing thyroid abnormality with thyroid stimulating hormone that cannot be maintained in the normal range with medication
  • Not pregnant or nursing
  • No known HIV infection
  • Able to swallow pills
    • No prior anticancer therapy for renal cell carcinoma in either the adjuvant or neoadjuvant setting
  • At least 2 weeks since prior and no concurrent treatment with any of the following*:
    • Cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, or phenobarbital)
    • Hypericum perforatum (St. John's wort)
    • Ketoconazole
    • Dexamethasone
    • Dysrhythmic drugs (i.e., terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide, or flecainide)
    • Haloperidol
    • Risperidone
    • Rifampin
    • Grapefruit juice or grapefruit
    • NOTE: * Topical and inhaled steroids are allowed
Speciality/Disorder  
Genitourinary Cancer
IRB Number  
09-06-12B
Principal Investigator  
Amin, Asim

For More Information, Contact  Melissa  , Morrison
Phone:  (704) 355-7024  Fax:  (704) 355-1188  
Email:  Melissa.Morrison@carolinashealthcare.org
Address:1025 Morehead Medical Drive
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