Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
Islet Cell Carcinoma, Neuroendocrine Carcinoma, Neuroendocrine Tumor
About this trial
This is an interventional treatment trial for Islet Cell Carcinoma focused on measuring Pancreatic, Tumor, Islet Cell, Carcinoma, Neuroendocrine, Endocrine, Atypical Carcinoid, RADIANT1, RADIANT-1
Eligibility Criteria
Inclusion criteria for both strata: Advanced (unresectable or metastatic) biopsy-proven pancreatic Neuroendocrine tumor (NET) Confirmed low-grade or intermediate-grade neuroendocrine carcinoma Objective disease progression by Response Evaluation Criteria in Solid tumors (RECIST) criteria while receiving cytotoxic chemotherapy or at any time after receiving an adequate course of cytotoxic chemotherapy (i.e., at least 3 consecutive cycles or months of treatment with the same cytotoxic drug or regimen) Presence of at least one measurable disease using RECIST criteria at screening (computer tomography [CT] or Magnetic resonance imaging [MRI]) Adequate bone marrow, liver and kidney function WHO Performance Status 0-2. Inclusion criteria for Stratum 2 only: Meet all inclusion criteria defined above for both strata. Receiving treatment (at least 3 consecutive months) with Octreotide Depot. In addition to documentation of progressive disease on or after chemotherapy, patients in stratum 2 must have documented objective progression of disease while receiving Octreotide Depot. Exclusion criteria for both strata: Anticancer therapy within 3 weeks of enrollment. Patients with poorly differentiated neuroendocrine carcinoma Hepatic artery embolization within the last 6 months Prior therapy with everolimus or other rapamycins (sirolimus, temsirolimus) Other concurrent malignancy Other serious intercurrent infections or nonmalignant uncontrolled medical illnesses Exclusion Criterion for Stratum 1 only: • Received treatment with Octreotide Depot or any other long-acting somatostatin analogue in the 60 days prior to enrollment or any short-acting somatostatin analogue in the two weeks prior to enrollment. Other protocol-defined inclusion/exclusion criteria applied.
Sites / Locations
- The University of Alabama at Birmingham
- USC Medical Center
- Cedars-Sinai Outpatient Cancer Center/Samuel Oschin Comprehensive Cancer Inst.
- UCLA Medical Center
- UCSF Comprehensive Cancer Center
- University of Miami
- H. Lee Moffit Cancer Center & Research Institute
- Emory University Hospital
- University of Iowa Hospitals and Clinics
- LSUHC Multispecialty Clinic
- Dana Farber Cancer Institute
- Mayo Clinic
- Dartmouth Hitchcock Medical Center
- Lynn Ratner, M.D.
- Duke University Medical Center
- Arthur G. James Cancer Hospital/Ohio State University
- Oregon Health and Science University
- M. D Anderson Cancer Center
- Scott & White Memorial Hospital
- University of Wisconsin Hospital & Clinics
- Novartis Investigative Site
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Arms of the Study
Arm 1
Experimental
Everolimus 10 mg
Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Stratum 2 patients who were to receive everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot therapy. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.