Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor (RADIANT-2)

Novartis

Status and phase: Completed; Phase 3

Conditions: Malignant Carcinoid Syndrome; Carcinoid Tumor

Treatments: Drug: Octreotide; Drug: Placebo; Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00412061

2006-004507-18 (EudraCT Number)

CRAD001C2325

Details and patient eligibility

About

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.

Enrollment: 429 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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429 participants in 2 patient groups, including a placebo group

Octreotide+ Everolimus

Experimental group

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.

Treatment:

Drug: Everolimus

Drug: Octreotide

Octreotide+ Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Octreotide