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