Spots Global Cancer Trial Database for Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
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Trial Identification
Brief Title: Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
Official Title: An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy
Study ID: NCT00363051
Study Description
Brief Summary: The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. All patients were treated with everolimus until either tumor progression was documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the patient or investigator requested discontinuation of treatment.
Detailed Description: This was a stratified two-stage, single-arm, phase 2 study of treatment with everolimus in patients with advanced (unresectable or metastatic) pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy. Stratum 1, consisted of patients not receiving chronic Octreotide Depot therapy, will receive everolimus monotherapy at 10 mg/day. Stratum 2, consisting of patients with tumors that have progressed during Octreotide Depot treatment will continue their entry dose of Octreotide Depot plus everolimus 10 mg/day.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Alabama at Birmingham, Birmingham, Alabama, United States
USC Medical Center, Los Angeles, California, United States
Cedars-Sinai Outpatient Cancer Center/Samuel Oschin Comprehensive Cancer Inst., Los Angeles, California, United States
UCLA Medical Center, Los Angeles, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
University of Miami, Miami, Florida, United States
H. Lee Moffit Cancer Center & Research Institute, Tampa, Florida, United States
Emory University Hospital, Atlanta, Georgia, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
LSUHC Multispecialty Clinic, New Orleans, Louisiana, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Lynn Ratner, M.D., New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Arthur G. James Cancer Hospital/Ohio State University, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
M. D Anderson Cancer Center, Houston, Texas, United States
Scott & White Memorial Hospital, Temple, Texas, United States
University of Wisconsin Hospital & Clinics, Madison, Wisconsin, United States
Novartis Investigative Site, Buenos Aires, , Argentina
Novartis Investigative Site, Santa Fe, , Argentina
Novartis Investigative Site, Heidelberg, , Australia
Novartis Investigative Site, Herston, , Australia
Novartis Investigative Site, Kogarah, , Australia
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Vancouver, British Columbia, Canada
Novartis Investigative Site, Halifax, Nova Scotia, Canada
Novartis Investigative Site, London, Ontario, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Billancourt, , France
Novartis Investigative Site, Clichy Cedex, , France
Novartis Investigative Site, Lyon Cedex, , France
Novartis Investigative Site, Reims, , France
Novartis Investigative Site, Toulouse, , France
Novartis Investigative Site, Villejuif Cedex, , France
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Erlangen, , Germany
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Heidelberg, , Germany
Novartis Investigative Site, Marburg, , Germany
Novartis Investigative Site, Ulm, , Germany
Novartis Investigative Site, Milano, , Italy
Novartis Investigative Site, Modena, , Italy
Novartis Investigative Site, Pisa, , Italy
Novartis Investigative Site, Rome, , Italy
Novartis Investigative Site, Torrette di Ancona, , Italy
Novartis Investigative Site, Gronigen, , Netherlands
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, L'Hospitalet de Llobregat, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Uppsala, , Sweden
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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