Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

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

Interventional

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)

Condition

Carcinoid Tumor

Intervention

Octreotide

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.

Publications

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

Recruitment Status

Drug

Estimated Enrollment

429

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, , 

Location Countries

Australia

Location Countries

Australia

NCT ID

NCT00412061

Organization ID

CRAD001C2325

Secondary IDs

2006-004507-18

Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals

Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Verification Date

November 2014