Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
Condition: Islet Cell Carcinoma; Neuroendocrine Carcinoma; Neuroendocrine Tumor; Pancreatic Neoplasms
MeSH terms: Carcinoma; Neuroendocrine Tumors; Pancreatic Neoplasms; Carcinoma, Neuroendocrine; Carcinoma, Islet Cell
Intervention: Everolimus 10 mg; Octreotide Depot
Intervention description: Participants took two 5 mg tablets of Everolimus orally with a glass of water, once daily (preferably in the morning) in a fasting state or after no more than a light, fat-free meal. Dosing was to occur at the same time each day. If vomiting occurred, the vomited dose was not to be replaced.
Intervention MeSH terms: Everolimus; Octreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic; Tumor; Islet Cell; Carcinoma; Neuroendocrine; Endocrine; Atypical Carcinoid; RADIANT1; RADIANT-1

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.
    

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.