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The ASSURE Study is a study of the possible benefits of Sutent (Sunitinib) manufactured & marketed by Pfizer & Nexavar (Sorafenib) manufactured & marketed by Bayer when used in an adjuvant or neo adjuvent role after surgery.


ASSURE Study Pfizer Letter 30-Jan-08


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

This study is currently recruiting participants. Verified by National Cancer Institute (NCI), January 2008

Sponsors and Collaborators: Eastern Cooperative Oncology Group National Cancer Institute (NCI) Cancer and Leukemia Group B Southwest Oncology Group National Cancer Institute of Canada

Information provided by: National Cancer Institute (NCI) Identifier: NCT00326898


RATIONALE: 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.

PURPOSE: 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.

Condition Intervention Phase Kidney Cancer

Drug: sorafenib tosylate

Drug: sunitinib malate Procedure: adjuvant therapy Procedure: antiangiogenesis therapy Procedure: conventional surgery Procedure: diagnostic procedure Procedure: enzyme inhibitor therapy Procedure: laboratory biomarker analysis Procedure: protein tyrosine kinase inhibitor therapy

Phase III

Genetics Home Reference related topics: Cancer Kidney Cancer

MedlinePlus related topics: Cancer Kidney Cancer

ChemIDplus related topics: Sunitinib Sunitinib malate Sorafenib Sorafenib tosylate Tyrosine Malic acid

U.S. FDA Resources

Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind

Official Title: ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures: Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures: Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 1332 Study Start Date: May 2006 Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

Detailed Description: OBJECTIVES:


Compare the disease-free survival of patients with locally advanced renal cell carcinoma treated with adjuvant sunitinib malate vs sorafenib vs placebo. Secondary

Compare overall survival of patients treated with these regimens. Define the toxicity of prolonged administration of sunitinib malate or sorafenib in these patients. Assess angiogenesis markers in tissue, blood, and urine as predictors of disease-free survival and therapeutic benefit. Assess the frequency of oncogene and tumor suppressor gene mutations as predictors of disease-free survival and therapeutic benefit. Assess tumor and genetic polymorphisms as predictors of disease-free survival and therapeutic benefit. Use DNA methylation profiles as predictors of outcome and therapeutic benefit. Correlate polymorphisms in drug-metabolizing enzymes with steady-state concentrations of sorafenib or sunitinib malate in selected patients. Study the effect of vascular endothelial growth factor-targeted therapy on circulating endothelial cells and circulating endothelial progenitors. OUTLINE: This is a randomized, double-blind, multicenter study. Patients who have not had surgical resection undergo radical or partial nephrectomy first. Patients are then stratified according to risk (intermediate high-risk vs very high-risk), histology (clear cell vs non-clear cell [except collecting duct or medullary]), ECOG performance status (0 vs 1), and the type of nephrectomy (laparoscopic vs open). Patients are randomized to 1 of 3 treatment arms.

Arm I: Patients receive oral sunitinib malate once daily on days 1-28 and oral placebo for sorafenib twice daily on days 1-42. Arm II: Patients receive oral sorafenib twice daily on days 1-42 and oral placebo for sunitinib malate once daily on days 1-28. Arm III: Patients receive oral placebo for sorafenib as in arm I and oral placebo for sunitinib malate as in arm II. In all arms, treatment repeats every 6 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Tumor tissue is collected prior to or during nephrectomy. Blood and urine samples are collected at baseline and periodically during study for biomarker correlative studies.

After completion of study treatment, patients are followed periodically for 9 years.

PROJECTED ACCRUAL: A total of 1,332 patients will be accrued for this study.


Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No



Histologically or cytologically confirmed renal cell carcinoma, including any of the following subtypes:

Clear cell carcinoma Nonclear cell carcinoma

No collecting duct or medullary carcinomas Meets 1 of the following risk categories:

Intermediate high-risk disease

pT1b, G3-4 pT2, G1-2 pT2, G3-4 pT3a, G1-2 (if pT3a is not due to adrenal involvement) Very high-risk disease

pT3a, G3-4 pT3a, any G (if pT3a is due to adrenal involvement) pTb or pTc, any G pT4, any G Any pT, any G, any N+ 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 pT1b-4, N0 or any fully resectable N (i.e., N1-2), M0 disease by radiologic criteria, meeting any of the following criteria:

Tumors ≥ 4 cm Macroscopic fully resectable nodes Surgically resectable renal vein thrombus Surgically resectable inferior vena caval thrombus by radiologic criteria 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 chest, abdomen, and pelvic CT scan with oral and IV contrast (or MRI scan of the abdomen and pelvis with gadolinium and a CT scan of the chest with or without IV contrast) within 4 weeks of randomization (after radical or partial nephrectomy) No history of distant metastases PATIENT CHARACTERISTICS:

ECOG performance status 0-1 Absolute granulocyte count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Creatinine ≤ 2.0 times upper limit of normal (ULN) OR creatinine clearance ≥ 30 mL/min Bilirubin ≤ 1.5 times ULN SGOT and SGPT ≤ 2.5 times ULN Absolute baseline LVEF ≥ 50% by MUGA within 4 weeks of randomization 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 New York Heart Association class II-IV congestive heart failure Peripheral vascular disease ≥ grade 2 Psychiatric illness or social situation that would preclude study compliance Ongoing or active infection requiring parenteral antibiotics 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 (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) QTc interval < 500 msec by baseline EKG No uncontrolled hypertension (i.e., diastolic blood pressure ≥ 100 mm Hg 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 Negative pregnancy test Fertile patients must use effective contraception No known HIV infection Able to swallow pills PRIOR CONCURRENT THERAPY:

Recovered from prior surgery No prior anticancer therapy for renal cell carcinoma in either the adjuvant or neoadjuvant setting, including any of the following:

Metastectomy Radiotherapy to the renal bed 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 Concurrent participation in protocol ECOG-E1Y03 allowed No other concurrent investigational anticancer agents

 Contacts and Locations

Please refer to this study by its identifier: NCT00326898

 Show 673 Study Locations 

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Southwest Oncology Group

National Cancer Institute of Canada


Study Chair: Naomi S. Balzer-Haas, MD Fox Chase Cancer Center

Investigator: Keith T. Flaherty, MD University of Pennsylvania

Investigator: Robert Uzzo, MD Fox Chase Cancer Center

Study Chair: Christopher J. Kane, MD UCSF Helen Diller Family Comprehensive Cancer Center

Study Chair: Christopher G. Wood, MD M.D. Anderson Cancer Center

Study Chair: Michael A.S. Jewett, MD Princess Margaret Hospital, Canada

 More Information 

Clinical trial summary from the National Cancer Institute's PDQ® database

Featured trial article

Study ID Numbers: CDR0000478976, ECOG-E2805, CALGB-E2805, SWOG-E2805, CAN-NCIC-E2805 First Received: May 16, 2006 Last Updated: January 23, 2008 Identifier: NCT00326898 Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI): clear cell renal cell carcinoma stage I renal cell cancer stage II renal cell cancer

 stage III renal cell cancer 

stage IV renal cell cancer papillary renal cell carcinoma

Study placed in the following topic categories: Pregnancy Complications Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Chromophil renal cell carcinoma Carcinoma Urologic Diseases


Kidney Neoplasms Carcinoma, Renal Cell Papillary renal cell carcinoma Kidney Diseases Clear cell renal cell carcinoma Sorafenib Urinary tract neoplasm

Additional relevant MeSH terms: Male Urogenital Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Angiogenesis Inhibitors Pharmacologic Actions

 Molecular Mechanisms of Action 

Neoplasms Female Urogenital Diseases and Pregnancy Complications Neoplasms by Site Female Urogenital Diseases Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents processed this record on January 24, 2008


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