Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor
NCT ID: NCT00412061
Last Updated: 2014-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
429 participants
INTERVENTIONAL
2006-12-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Octreotide+ Everolimus
Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
Octreotide
Octreotide 30 mg intramuscularly (i.m.) every 28 days.
Everolimus
A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.
Octreotide+ Placebo
Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
Octreotide
Octreotide 30 mg intramuscularly (i.m.) every 28 days.
Placebo
A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo.
Interventions
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Octreotide
Octreotide 30 mg intramuscularly (i.m.) every 28 days.
Placebo
A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo.
Everolimus
A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
* Documented progression of disease within 12 months prior to randomization.
* Measurable disease determined by triphasic computer tomography (CT) scan or magnetic resonance imaging (MRI).
Exclusion Criteria
* Hepatic artery embolization within the last 6 months or cryoablation of hepatic metastasis within 2 months of enrollment.
* Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus, temsirolimus, everolimus)
* Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.
* Severe or uncontrolled medical conditions
* Chronic treatment with corticosteroids or other immunosuppressive agent.
* Other primary cancer within 3 years.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of Arizona / Arizona Cancer Center Deptof Uof A/Arizona Cancer(2)
Tucson, Arizona, United States
Highlands Oncology Group The Center for Chest Care
Fayetteville, Arkansas, United States
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States
Cedars Sinai Medical Center SC-2
Los Angeles, California, United States
University of California at Los Angeles UCLA New SC Address
Los Angeles, California, United States
University of Colorado Dept. of Univ. of Colorado
Aurora, Colorado, United States
Rocky Mountain Cancer Centers Dept of Rocky Mountain (2)
Denver, Colorado, United States
Eastern Connecticut Hematology & Oncology Associates Dept. of ECHO
Norwich, Connecticut, United States
Cancer Centers of Connecticut Southington Location
Southington, Connecticut, United States
Hematology Oncology PC Dept.of Hematology Oncology(2)
Stamford, Connecticut, United States
Ocala Oncology Center Dept. of Ocala Oncology Center
Ocala, Florida, United States
Cancer Care and Hematology Specialists of Chicagoland Niles
Niles, Illinois, United States
Indiana University Dept.of IndianaUniv.CancerCtr
Indianapolis, Indiana, United States
Central Indiana Cancer Centers CICC - South
Indianapolis, Indiana, United States
University of Iowa Medical Center Internal Medicine
Iowa City, Iowa, United States
University of Kansas Cancer Center Deptof Uof Kansas CancerCenter
Kansas City, Kansas, United States
Kansas City Cancer Center KCCC Business Office
Overland Park, Kansas, United States
Norton Cancer Institute Clinical Research Program
Louisville, Kentucky, United States
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2)
New Orleans, Louisiana, United States
Mayo Clinic - Rochester Division of Hematology
Rochester, Minnesota, United States
Washington University School Of Medicine-Siteman Cancer Ctr Division of Oncology
St Louis, Missouri, United States
The Center for Cancer Care and Research
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center Medical Oncology
Lebanon, New Hampshire, United States
New York Oncology Hematology, P.C. Dept. of New York Oncology. PC
Albany, New York, United States
New York University Medical Center NYU Medical Center (2)
New York, New York, United States
Duke University Medical Center Dept. of Duke Cancer Center
Durham, North Carolina, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Cancer Centers of the Carolinas CC of C -Eastside
Greenville, South Carolina, United States
Texas Oncology, P.A. Central Austin Cancer Center
Austin, Texas, United States
South Texas Institute of Cancer S. Tex Inst.- Corpus Christi
Corpus Christi, Texas, United States
Sammons Cancer Center - Texas Oncology Sammons Cancer Center (SC)
Dallas, Texas, United States
Texas Oncology, P.A. Forth Worth -- 12th Avenue
Fort Worth, Texas, United States
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
Houston, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Virginia Oncology Associates VOA - Lake Wright
Norfolk, Virginia, United States
Northwest Cancer Specialists Compass Oncology -BKM
Vancouver, Washington, United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center GI Oncology Research Center
Madison, Wisconsin, United States
Novartis Investigative Site
Kogarah, New South Wales, Australia
Novartis Investigative Site
Herston, Queensland, Australia
Novartis Investigative Site
South Brisbane, Queensland, Australia
Novartis Investigative Site
Brussels, , Belgium
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Prague, Czech Republic, Czechia
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Příbram, , Czechia
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Helsinki, , Finland
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Strasbourg, France, France
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Clichy Cédex, , France
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Lille, , France
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Montpellier, , France
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Paris, , France
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Toulouse, , France
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Villejuif, , France
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Berlin, , Germany
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Hamburg, , Germany
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Athens, Greece, Greece
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Bologna, BO, Italy
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Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
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Perugia, PG, Italy
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Pisa, PI, Italy
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Groningen, , Netherlands
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Rotterdam, , Netherlands
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Bratislava, Slovak Republic, Slovakia
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Madrid, Madrid, Spain
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Uppsala, , Sweden
Novartis Investigative Site
Basingstoke, , United Kingdom
Countries
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References
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Pavel ME, Baudin E, Oberg KE, Hainsworth JD, Voi M, Rouyrre N, Peeters M, Gross DJ, Yao JC. Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study. Ann Oncol. 2017 Jul 1;28(7):1569-1575. doi: 10.1093/annonc/mdx193.
Fazio N, Granberg D, Grossman A, Saletan S, Klimovsky J, Panneerselvam A, Wolin EM. Everolimus plus octreotide long-acting repeatable in patients with advanced lung neuroendocrine tumors: analysis of the phase 3, randomized, placebo-controlled RADIANT-2 study. Chest. 2013 Apr;143(4):955-962. doi: 10.1378/chest.12-1108.
Pavel ME, Hainsworth JD, Baudin E, Peeters M, Horsch D, Winkler RE, Klimovsky J, Lebwohl D, Jehl V, Wolin EM, Oberg K, Van Cutsem E, Yao JC; RADIANT-2 Study Group. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study. Lancet. 2011 Dec 10;378(9808):2005-2012. doi: 10.1016/S0140-6736(11)61742-X. Epub 2011 Nov 25.
Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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2006-004507-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRAD001C2325
Identifier Type: -
Identifier Source: org_study_id