Conditions: Carcinoid Tumor Malignant Carcinoid Syndrome
Keywords: Cancer Carcinoid Tumor Neuroendocrine Carcinoma Everolimus Octreotide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 429
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 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. arm 2: Matching placebo 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 matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.

Interventions: intervention 1: Octreotide intervention 2: Placebo intervention 3: Everolimus
Intervention descriptions: intervention 1: Octreotide 30 mg intramuscularly (i.m.) every 28 days. intervention 2: A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo. intervention 3: A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.

Protocol document: