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Clinical Trials (PDQ®)

Clinical Trials (PDQ®)

S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITissue collection/Repository, TreatmentActive18 and overNCI, OtherCDR0000668388
S0931, U10CA032102, SWOG-S0931, NCT01120249

Trial Description

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

PURPOSE: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.

Further Study Information

OBJECTIVES:

Primary

  • to compare recurrence-free survival in renal carcinoma patients randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy.

Secondary

  • To compare the overall survival of patients treated with everolimus vs placebo.
  • To compare qualitative and quantitative toxicity between the two study arms.
  • To bank tissue and biologic specimens for future study of molecular biomarkers relevant to the AKT/mTOR and other pathways implicated in the pathogenesis of renal carcinoma and to investigate their potential predictive and prognostic value.
  • To bank blood specimens for the future study of the relationship between steady-state trough levels of everolimus and relevant side effects (lymphopenia, infection, hyperglycemia, hypercholesterolemia, hypertriglyceridemia) in patients treated on this study with everolimus.

OUTLINE: This is a multicenter study.

Patients are stratified according to pathologic stage (intermediate high-risk vs very high-risk), histologic subtype (clear cell vs non-clear cell), and performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.

Archived tumor tissue, plasma, and whole blood samples may be collected periodically for biomarker analysis and other translational studies.

After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 8 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed renal cell carcinoma
  • Clear cell or non-clear cell allowed
  • No disease of the collecting duct or medullary carcinoma
  • Considered pathologically either intermediate high-risk or very high-risk disease
  • No history of distant metastases
  • Patients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are eligible
  • Have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) including removal of all clinically positive nodes
  • Surgical margins must be negative
  • 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 be registered within 84 days after the date of the first surgical resection of the first tumor
  • No evidence of residual or metastatic renal cell cancer on CT scan of the chest, abdomen, and pelvis (all with oral and IV contrast) performed after nephrectomy and within 28 days before registration
  • MRI scans of the abdomen and pelvis with gadolinium and a non-contrast CT scan of the chest may be substituted if the patient is not able to have CT scans with IV contrast

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Serum creatinine ≤ 2.0 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 30 mL/min
  • Bilirubin ≤ 1.5 times ULN
  • SGOT and SGPT ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment
  • Able to take oral medications
  • Patients must not have any of the following:
  • NYHA class III-IV cardiac disease (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort)
  • Unstable angina pectoris
  • Myocardial infarction within the past 6 months
  • Serious uncontrolled cardiac arrhythmia
  • Patients must NOT have liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C)
  • HBV and HCV testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
  • Must be able to take oral medications
  • No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • No known history of HIV seropositivity
  • No known uncontrolled, underlying pulmonary disease (spirometry and DLCO ≤ 50% of predicted OR oxygen saturation ≤ 88% at rest on room air)
  • No uncontrolled hyperlipidemia (fasting serum cholesterol > 300 mg/dL AND fasting triglycerides > 2.5 times ULN) obtained within 28 days prior to registration
  • Optimal lipid control must be achieved before registration and monitored during protocol treatment
  • No uncontrolled diabetes mellitus (defined by fasting serum glucose > 1.5 times ULN) obtained within 28 days prior to registration.
  • Optimal glucose control must be achieved before registration and monitored during protocol treatment
  • No prior malignancies except for any of the following:
  • Adequately treated basal cell or squamous cell skin cancer
  • In situ cervical cancer
  • Adequately treated stage I or stage II cancer from which the patient is currently in complete remission
  • Any other cancer from which the patient has been disease-free for 5 years
  • No known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to their excipients
  • No contraindications to receiving either IV iodine-based contrast or gadolinium

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Patients must have recovered from any surgery-related complications
  • No prior anticancer therapy for renal cell carcinoma including systemic therapy in the adjuvant or neoadjuvant setting, immunotherapy, investigational therapy, surgical metastasectomy, or radiotherapy
  • More than 14 days since prior and no concurrent strong CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, voriconazole, posaconazole, fluvoxamine, nefazodone, nelfinavir, or ritonavir) or strong CYP3A4 inducers (i.e., phenytoin, rifampin, or rifabutin)
  • More than 7 days since prior and no concurrent live vaccines
  • No other concurrent anticancer agents including investigational agents
  • No concurrent chronic treatment with systemic steroids or another immunosuppressive agent
  • Topical or inhaled corticosteroids are allowed

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

National Cancer Institute

Christopher W. RyanPrincipal Investigator

Gilbert CarrizalesPh: 2106148808
  Email: gcarrizales@swog.org

Trial Sites

U.S.A.
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Stephen Scott Grubbs Ph: 302-733-6227
  Newark
 Christiana Gynecologic Oncology, LLC
 Stephen Scott Grubbs Ph: 302-733-6227
 Delaware Clinical and Laboratory Physicians
 Stephen Scott Grubbs Ph: 302-733-6227
 Helen F. Graham Cancer Center at Christiana Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
 Stephen Scott Grubbs Ph: 302-733-6227
 Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center
 Stephen Scott Grubbs Ph: 302-733-6227
 Regional Hematology/Oncology, PA - Newark
 Stephen Scott Grubbs Ph: 302-733-6227
  Rehoboth Beach
 Beebe Health Campus
 Stephen Scott Grubbs Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
  Wilmington
 Christiana Care Health System-Wilmington Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
District of Columbia
  Washington
 George Washington University Cancer Institute
 Jeanny B Aragon-Ching Ph: 202-741-2981
Maryland
  Baltimore
 Greater Baltimore Medical Center Cancer Center
 Gary I. Cohen Ph: 443-849-3706
 Greenebaum Cancer Center at University of Maryland Medical Center
 Heather D Mannuel Ph: 800-888-8823
  Easton
 Shore Regional Cancer Center at Memorial Hospital - Easton
 John P. Foley Ph: 410-820-6800ext108
  Email: srichter@shorehealth.org
  Silver Spring
 Holy Cross Hospital
 Kashif Ali Ph: 310-754-7552
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Robert A Somer Ph: 856-325-6757
  East Orange
 Veterans Affairs Medical Center - East Orange
 Basil S. Kasimis Ph: 800-475-2336
  Email: patricia.goyer@med.va.gov
  Livingston
 St. Barnabas Medical Center Cancer Center
 Stuart P. Leitner Ph: 973-322-2470
  Morristown
 Carol G. Simon Cancer Center at Morristown Memorial Hospital
 Bonni L Guerin Ph: 908-522-2043
  Sewell
 Radiation Oncology Center at Kennedy Health System - Sewell
 Trina A Poretta Ph: 888-847-8823
  Somerville
 Somerset Medical Center
 Steven E Young Ph: 908-685-2481
  Summit
 Overlook Hospital
 Bonni L Guerin Ph: 908-522-2043
  Vineland
 Frank and Edith Scarpa Regional Cancer Pavillion at South Jersey Healthcare
 Benjamin P Negin Ph: 856-641-7933
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Robert A Somer Ph: 856-325-6757
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Willard G. Andrews Ph: 215-481-2402
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Eliot Lawrence Friedman Ph: 610-402-2273
  Bethlehem
 Lehigh Valley Hospital - Muhlenberg
 Eliot Lawrence Friedman Ph: 610-402-2273
  Bryn Mawr
 Bryn Mawr Hospital
 Albert S DeNittis Ph: 866-225-5654
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Christian Adonizio Ph: 570-271-5251
  Doylestown
 Doylestown Hospital Cancer Center
 Mitchell Alden Ph: 215-345-2378
  Email: lheacock@dh.org
  Drexel Hill
 Delaware County Regional Cancer Center at Delaware County Memorial Hospital
 Stephen A. Shore Ph: 610-284-8237
  Email: jolene.garney@crozer.org
  Easton
 Easton Regional Cancer Center at Easton Hospital
 Sonyo Shin Ph: 610-250-4000
  Hazleton
 Geisinger Hazleton Cancer Center
 Christian Adonizio Ph: 570-271-5251
  Lancaster
 Lancaster General Hospital
 Shanthi Sivendran Ph: 717-544-5511
  Lewisburg
 Geisinger Medical Oncology at Evangelical Community Hospital
 Christian Adonizio Ph: 570-271-5251
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Albert S DeNittis Ph: 866-225-5654
  Philadelphia
 Abramson Cancer Center of the University of Pennsylvania
 Stephen M Keefe Ph: 800-474-9892
 Fox Chase Cancer Center - Philadelphia
 Yu-Ning Wong Ph: 215-728-4790
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Jean H Hoffman-Censits Ph: 215-955-6084
 Temple Cancer Center at Temple University Hospital
 Alvaro Pereira-Rico Ph: 215-728-2983
  Pottstown
 Pottstown Memorial Regional Cancer Center
 Wei Song Ph: 610-327-7544
  Pottsville
 Geisinger Medical Oncology-Pottsville
 Christian Adonizio Ph: 570-271-5251
  West Chester
 Cancer Center of Chester County
 William E. Luginbuhl Ph: 610-431-5297
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Terrence P. Cescon Ph: 610-988-9323
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Christian Adonizio Ph: 570-271-5251
  Williamsport
 Susquehanna Cancer Center at Divine Providence Hospital
 Warren L Robinson Ph: 800-598-4282
  Wynnewood
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01120249
ClinicalTrials.gov processed this data on February 25, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.