ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
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 not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Sorafenib
- drug : Sunitinib
- other : placebo
Phase: Phase 3
Ages Eligible For Study:
- 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 disease - 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 well - 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 requirements - 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 0-1 - 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 specified - 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