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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITissue collection/Repository, TreatmentActive18 and overNCI, OtherS0931
U10CA032102, NCI-2011-02028, 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. Ryan, Principal Investigator
Jennifer Scott
Ph: 2106148808 Ext.1007
Email: jscott@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

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

Victor T Chang
Ph: 800-475-2336
Email: patricia.goyer@med.va.gov

Morristown

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Bonni L Guerin
Ph: 908-522-2043

New Brunswick

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Tina Mayer
Ph: 732-235-8675

Tina Mayer
Ph: 732-235-8675

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

Woodbury

Underwood Memorial Hospital

Benjamin P Negin
Ph: 856-641-7933

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

Hershey

Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

Monika Joshi
Ph: 717-531-3779
Email: CTO@hmc.psu.edu

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

Naomi S. Balzer-Haas
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

Sellersville

Grand View Hospital

Anthony J Magdalinski
Ph: 215-453-4162
Email: PParsons@gvh.org

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 Identifier NCT01120249
ClinicalTrials.gov processed this data on February 16, 2015

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.