Trial Search Results

Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery

This randomized phase III trial studies sunitinib malate and sorafenib tosylate to see how well they work compared to placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate 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 malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate or sorafenib tosylate is more effective than placebo in treating kidney cancer.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Collaborator: Cancer and Leukemia Group B

Stanford Investigator(s):


  • Other: Placebo
  • Drug: Sorafenib
  • Drug: Sunitinib


Phase 3


Pre-Registration Inclusion Criteria:

   - Pre-surgical criteria:

      - Patients must have primary-intact renal cell carcinoma, eligible for nephrectomy
      with curative intent

      - Tumors >= 4 cm AND/OR macroscopic fully resectable nodes AND/OR surgically
      resectable renal vein thrombus AND/OR surgically resectable inferior vena caval
      thrombus by radiologic criteria to be clinically >= pT1bNany (resectable) M0

      - Multifocal ipsilateral renal cell carcinoma is allowed provided fully resectable
      and does not exceed inclusion criteria

   - Patients must have corrected QT (QTc) interval < 500 msec on baseline
   electrocardiogram (EKG)

   - Women of child-bearing potential and men must agree to use an accepted and effective
   method of contraception prior to study entry and for the duration of study
   participation; should a woman become pregnant while participating in this study, she
   should inform her treating physician immediately; if a man impregnates a woman while
   participating in this study, he should inform his treating physician immediately as

   - The date of randomization must be less than 12 weeks after the date of surgery;
   patients must have recovered from any surgical related complications

Inclusion Criteria at Randomization:

   - Within 4 weeks prior to randomization, patients must meet preoperative eligibility

   - Patients must complete surgery less than 12 weeks prior to randomization

   - Patients must have histologically or cytologically confirmed renal cell carcinoma.
   Using 2002 (American Joint Committee on Cancer [AJCC] 6th edition) TNM Staging,
   patients must be one of the following:

      - pT1b G3-4 N0 (or pNX where clinically N0) M0

      - pT2 G (any) N0 (or pNX where clinically N0) M0

      - pT3 G (any) N0 (or pNX where clinically N0) M0

      - pT4 G (any) N0 (or pNX where clinically N0) M0 or

      - T (any) G (any) N+ (fully resected) M0

         - Patients with microvascular invasion of the renal vein of any grade or stage
         (as long as M0) are also eligible

         - Patients must have undergone a full surgical resection (radical nephrectomy
         or partial nephrectomy) by either open or laparoscopic technique; clinical
         evidence of lymph node positivity requires removal of all clinically
         positive nodes; surgeons should designate extent of node dissection; all
         surgical specimens must have negative margins; patients with positive renal
         vein margins are eligible unless there is invasion of the renal vein wall at
         the margin (provided no other margins are positive)

   - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of

   - Patients must have an absolute baseline left ventricular ejection fraction (LVEF) of
   >= 50% by multigated acquisition (MUGA) scan within 4 weeks prior to randomization

   - Patients must have paraffin-embedded tumor specimen available for central core review
   of tumor histology and other correlative studies; tumor samples will be shipped as

   - Patients must have no evidence of residual or metastatic renal cell cancer as
   documented on computed tomography (CT) scans of the chest, abdomen, and pelvis, all
   with oral and intravenous (IV) contrast (magnetic resonance imaging [MRI] scans of the
   abdomen and pelvis with gadolinium and a non-contrast CT of the chest may be
   substituted if patient is not able to have CT scans with intravenous contrast);
   patients unable to tolerate either gadolinium or IV contrast should not participate in
   this study (limitations to a patient's renal function should be taken into
   consideration when screening for this study)

      - Scans must be obtained within 4 weeks of randomization; changes on these scans
      that are felt to be post surgical must be documented

      - Patients without reported lymph nodes in the resected surgical specimen and a
      reported pathologic stage (post-nephrectomy) of pNX MUST undergo a post-operative
      contrast-enhanced CT scan (or MRI with gadolinium) within 4 weeks of
      randomization to document that there is no evidence of residual disease

   - Absolute granulocyte count (AGC) >= 1,500/mm^3

   - Platelet count >= 100,000/mm^3

   - Serum creatinine =< 2.0 x upper limit of normal (ULN) or calculated creatinine
   clearance (CrCl) >= 30 mL/min (neither drug is cleared by the kidney)

   - Total bilirubin =< 1.5 x upper limit of normal (ULN)

   - Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate
   transaminase (SGPT) =< 2.5 x ULN

   - Patients must be able to swallow pills

Exclusion Criteria:

   - History of distant metastases

   - Prior anti-cancer therapy for renal cell carcinoma in either the adjuvant or
   neoadjuvant setting; this includes metastatectomy for renal cell carcinoma, or
   radiation therapy to the renal bed

   - Other current malignancies, other than basal cell skin cancer, squamous cell skin
   cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast;
   patients with other malignancies are eligible if they have been continuously
   disease-free for >= 5 years prior to the time of registration

   - Serious intercurrent illness including, but not limited to, the following: clinically
   significant cardiovascular disease (e.g. uncontrolled hypertension, myocardial
   infarction, unstable angina); New York Heart Association grade II or greater
   congestive heart failure; serious cardiac arrhythmia requiring medication; grade II or
   greater peripheral vascular disease; or psychiatric illness/social situations that
   would limit compliance with study requirements

   - Any of the following within the 6 months prior to study drug administration:
   myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
   graft, symptomatic congestive heart failure, cerebrovascular accident or transient
   ischemic attack, or pulmonary embolism

   - Ongoing ventricular cardiac dysrhythmias of National Cancer Institute Common
   Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 grade >= 2; history of
   serious ventricular arrhythmia (ventricular tachycardia [VT] or ventricular
   fibrillation [VF] >= 3 beats in a row); ongoing atrial fibrillation

   - Hypertension that cannot be controlled by medications (>= diastolic blood pressure 100
   mm Hg despite optimal medical therapy)

   - Pre-existing thyroid abnormality with thyroid stimulating hormone that cannot be
   maintained in the normal range with medication

   - Pregnant or breastfeeding; all females of childbearing potential must have a blood
   test or urine study within 2 weeks prior to pre-registration to rule out pregnancy; if
   pre-registration occurs prior to surgery, the blood or urine study must be repeated
   within 2 weeks prior to randomization to rule out pregnancy; (note: should a woman
   become pregnant while participating in this study, she should inform her treating
   physician immediately)

   - Patients with known human immunodeficiency virus (HIV)

   - Collecting duct carcinomas or medullary carcinomas

   - Patients taking cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin,
   carbamazepine or phenobarbital), St John's Wort, ketoconazole, dexamethasone, the
   dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol, probucol, bepridil,
   indapamide or flecainide), haloperidol, risperidone, rifampin, grapefruit, or
   grapefruit juice within two weeks of randomization and during the course of therapy;
   (medications are not prohibited unless listed above); topical and inhaled steroids are

   - Receiving any other investigational anti-cancer agents during the period on study

   - Serious intercurrent illness, including ongoing or active infection requiring parental

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting