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Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor
This study is ongoing, but not recruiting participants.
First Received: December 13, 2006   Last Updated: November 18, 2009   History of Changes
Sponsor: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00412061
  Purpose

The purpose of this study is to evaluate whether everolimus 10 mg / day added to treatment with octreotide depot prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.


Condition Intervention Phase
Carcinoid Tumor
Malignant Carcinoid Syndrome
 Drug: Octrotide with Everolimus
Drug: Octrotide depot with placebo
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo

Resource links provided by NLM:

MedlinePlus related topics: Cancer Carcinoid Tumors
Drug Information available for: Octreotide acetate Octreotide Everolimus
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression Free Survival (PFS)evaluated per central radiological assessment. [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • To characterize the PK of RAD001 and Sandostatin LAR® depot administered in combinations [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate best overall response rand response reduction [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • T compare overall survival between study arms. [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • To compare changes from baseline in 5-HIAA and chromogranin-A [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To determine the safety and tolerability of the combination of RAD001 plus Sandostatin LAR® depot. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 390
Study Start Date: December 2006
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sandostatin LAR® depot with RAD001: Experimental Drug: Octrotide with Everolimus
Sandostatin LAR® depot with placebo: Placebo Comparator Drug: Octrotide depot with placebo

  Eligibility

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

Inclusion criteria

  • Advanced (unresectable or metastatic) carcinoid tumor
  • Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
  • Documented progression of disease within 12 months prior to enrollment.
  • Measurable disease determined by Triphasic CT scan or MRI.

Exclusion criteria

  • Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.
  • Hepatic artery embolization within the last 6 months or cryoablation of hepatic metastasis within 2 months of enrollment.
  • Previous treatment with 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.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412061

  Hide Study Locations
Locations
United States, Arizona
University of Arizona-Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Highlands Oncology Group, PA
Fayetteville, Arkansas, United States, 72703
Hematology, Oncology Services of Arkansas (H.O.S.A.)
Little Rock, Arkansas, United States, 72205
United States, California
Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
United States, Colorado
University of Colorada Health Sciences Center
Aurora, Colorado, United States, 80045
USO
Denver, Colorado, United States, 80218
United States, Connecticut
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, United States, 06360
Oncology, PC
Stamford, Connecticut, United States, 06902
Cancer Center of Central Connecticut
Southington, Connecticut, United States, 06489
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Ocala Oncology
Ocala, Florida, United States, 34474
United States, Illinois
US Oncology
Arlington Heights, Illinois, United States, 60005
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
US Oncology
Indianapolis, Indiana, United States, 46227
United States, Iowa
University of Iowa Medical Center
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
Kansas City Cancer Center (Southwest)
Overland Park, Kansas, United States, 66210
United States, Kentucky
Louisville Oncology Research Program
Lousville, Kentucky, United States, 40202
United States, Louisiana
Louisiana State University Health Sciences Center
Kenner, Louisiana, United States, 70065
United States, Minnesota
Mayo Clinic Division of Medical Oncology
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine-Siteman Cancer Center
St. Louis, Missouri, United States, 63110
Care and Research
St. Louis, Missouri, United States, 63141
United States, New Hampshire
Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
NYU Cancer Institute
New York, New York, United States, 10016
York Oncology Hematology
Albany, New York, United States, 12208
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals of Cleveland-Ireland Cancer Center
Cleveland, Ohio, United States, 44106
Greater Dayton Cancer Center
Kettering, Ohio, United States, 45409
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29615
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
South Texas Cancer Center
Corpus Christi, Texas, United States, 78405
Scott & White Hospital
Temple, Texas, United States, 76508
US Oncology/Sammons Cancer Center
Dallas, Texas, United States, 75246
Tyler Cancer Center
Tyler, Texas, United States, 75702
US Oncology - Texas Oncology P.A.
Austin, Texas, United States, 78731
US Oncology - Texas Oncology 12th Avenue
Fort Worth, Texas, United States, 76104
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
US Oncology
Vancouver, Washington, United States, 98684
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Australia
Novartis Investigative Site
Herston, Australia, 4029
Novartis Investigative Site
Heidelburg, Australia, 3084
Novartis Investigative Site
East Melbourne, Australia, 3002
Novartis Investigative Site
Woodville, Australia, 5011
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Additional Information:
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CRAD001C2325
Study First Received: December 13, 2006
Last Updated: November 18, 2009
ClinicalTrials.gov Identifier: NCT00412061     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Cancer
Carcinoid
Tumor
Neuroendocrine
 Carcinoma
Everolimus
Octreotide

Additional relevant MeSH terms:
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Disorders of Environmental Origin
Octreotide
Pathologic Processes
Neoplasms, Germ Cell and Embryonal
Syndrome
Therapeutic Uses
Everolimus
Neoplasms by Histologic Type
Disease
Antineoplastic Agents, Hormonal
 Serotonin Syndrome
Poisoning
Gastrointestinal Agents
Malignant Carcinoid Syndrome
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Drug Toxicity
Carcinoid Tumor
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009



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