Overview

Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Everolimus
Octreotide
Sirolimus
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