Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

Learn more about:
Related Clinical Trial
Bronchoscopic Laser Ablation of Peripheral Lung Tumors Physical Activity Intervention Before and After Surgery in Older Adults With Lung Cancer and Their Family Caregivers Personalized PRRT of Neuroendocrine Tumors Clinical and Pathologic Studies in Neuroendocrine Tumors Nivolumab With Ipilimumab in Subjects With Neuroendocrine Tumors Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs) Active Surveillance in Early Lung Cancer Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma 68Ga-Dotatoc Positron Emission Tomography (PET) for Somatostatin Receptor-Positive Neuroendocrine Tumors (NETs) Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion Carcinoid Heart Disease and Peptide Receptor Radiotargetted Therapy Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease Cabozantinib and Nivolumab for Carcinoid Tumors Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor Ziv-Aflibercept for Advanced Progressive Carcinoid Tumors A Combination Study to Determine the Safety and Efficacy of Panzem NCD With Avastin in Metastatic Carcinoid Tumors A Study of Sunitinib Versus Placebo in Combination With Lanreotide in Patients With Progressive Advanced/Metastatic Midgut Carcinoid Tumors Endoscopic Treatment of Bronchial Carcinoid Tumors Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors A Study of Axitinib in Advanced Carcinoid Tumors A Phase II Study of Ramucirumab With Somatostatin Analog Therapy in Patients With Advanced, Progressive Carcinoid Tumors

Brief Title

Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

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

Brief Summary

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

Study Phase

Phase 3

Study Type


Primary Outcome

Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review

Secondary Outcome

 Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST)


Carcinoid Tumor



Study Arms / Comparison Groups

 Octreotide+ Everolimus
Description:  Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

December 2006

Completion Date

June 2013

Primary Completion Date

April 2010

Eligibility 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 randomization.

          -  Measurable disease determined by triphasic computer tomography (CT) scan or magnetic
             resonance imaging (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 mammalian target of rapamycin (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 applied




18 Years - N/A

Accepts Healthy Volunteers



Novartis Pharmaceuticals, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

Novartis Pharmaceuticals

Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Verification Date

November 2014