Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

Summary

This phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.

Conditions

• Functioning Pancreatic Neuroendocrine Tumor
• Intermediate Grade Lung Neuroendocrine Neoplasm
• Locally Advanced Digestive System Neuroendocrine Neoplasm
• Locally Advanced Digestive System Neuroendocrine Tumor G1
• Locally Advanced Lung Neuroendocrine Neoplasm
• Locally Advanced Pancreatic Neuroendocrine Tumor
• Locally Advanced Unresectable Digestive System Neuroendocrine Neoplasm
• Low Grade Lung Neuroendocrine Neoplasm
• Lung Neuroendocrine Tumor
• Lung Neuroendocrine Tumor G2
• Metastatic Digestive System Neuroendocrine Neoplasm
• Metastatic Digestive System Neuroendocrine Tumor G1
• Metastatic Lung Neuroendocrine Neoplasm
• Metastatic Lung Neuroendocrine Tumor
• Metastatic Pancreatic Neuroendocrine Neoplasm
• Metastatic Pancreatic Neuroendocrine Tumor
• Metastatic Thymus Neuroendocrine Neoplasm
• Neuroendocrine Neoplasm
• Neuroendocrine Tumor
• Neuroendocrine Tumor G2
• Non-Functioning Pancreatic Neuroendocrine Tumor
• Pancreatic Serotonin-Producing Neuroendocrine Tumor
• Thymus Neuroendocrine Tumor
• Unresectable Digestive System Neuroendocrine Neoplasm
• Unresectable Digestive System Neuroendocrine Tumor G1
• Unresectable Lung Neuroendocrine Neoplasm
• Unresectable Pancreatic Neuroendocrine Neoplasm
• Unresectable Thymus Neuroendocrine Neoplasm

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and urine sample collection

DRUG

Cabozantinib S-malate

Given PO

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Placebo Administration

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

PROCEDURE

X-Ray Imaging

Undergo x-ray

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Jennifer A Chan · Alliance for Clinical Trials in Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-26

Primary Completion

2023-08-23

Completion

2026-08-19

FDA Drug

Yes

Countries

• United States

Study Locations