An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.
from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)
United States: Food and Drug Administration
|The University of Alabama at Birmingham||Birmingham, Alabama 35294|
|Mayo Clinic||Rochester, Minnesota 55905|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|
|Duke University Medical Center||Durham, North Carolina 27710|
|University of Wisconsin Hospital & Clinics||Madison, Wisconsin 53792|
|UCLA Medical Center||Los Angeles, California 90095-7059|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Dartmouth Hitchcock Medical Center||Lebanon, New Hampshire 03756|
|Scott & White Memorial Hospital||Temple,, Texas 76508|
|University of Miami||Miami, Florida 33136|
|Oregon Health and Science University||Portland, Oregon 97201|
|Emory University Hospital||Atlanta, Georgia 30322|
|Cedars-Sinai Outpatient Cancer Center/Samuel Oschin Comprehensive Cancer Inst.||Los Angeles, California 90048|
|USC Medical Center||Los Angeles, California 90033|
|H. Lee Moffit Cancer Center & Research Institute||Tampa, Florida 33612|
|LSUHC Multispecialty Clinic||New Orleans, Louisiana 70115|
|Lynn Ratner, M.D.||New York, New York 10028|
|Arthur G. James Cancer Hospital/Ohio State University||Columbus, Ohio 43210|
|M. D Anderson Cancer Center||Houston, Texas 77030|