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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Renal Cancer
Title   A Study of Adjuvant Sunitinib vs Sorafenib vs Placebo in Patients with Resected Renal Cell Cancer
Description   Sunitinib and sorafenib 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. Giving sunitinib or sorafenib after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib is more effective than sorafenib or placebo in treating kidney cancer. 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.
IRB Number   Pro80
Inclusion/Notes   INCLUSION:
  • Pre or post surgery and at least 18 years of age.

  • No history of distant metastases.

  • No prior anti-cancer therapy.

  • Must have QTc interval < 500 msec on baseline EKG.

  • Must have an absolute baseline ejection fraction of =50% by gated MUGA.

EXCLUSION:
  • Patients with hypertension that cannot be controlled by medication.

  • Pregnant or breast-feeding women.

  • Patients with known HIV.

  • Patients with other current malignancies other than basal skin cancer, squamous cell cancer, in situ cervical cancer, ductal or lobular cancer in situ of breast.

  • Patients with a serious intercurrent illness.

  • Patients who have had any of the following within 6 months prior to study drug administration: MI, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF, CVA, TIA, or PE.

  • Patients with ongoing cardiac dysrhythmias or pre-existing thyroid abnormality with thyroid stimulating hormone that cannot be maintained in the normal range with medication.
Status   Active - not Recruiting
Location   Texas Health Presbyterian Dallas
Principal Name    James Fredric Strauss MD
Contact Name   Claire Peterson, RN, BSCN, CCRC
Phone   (214) 345-4121

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