Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma

Paraganglioma Clinical Trial

Official title: Phase I Study of Anti-IGF-1R Monoclonal Antibody, IMC-A12, and mTOR Inhibitor, Everolimus, in Advanced Low to Intermediate Grade Neuroendocrine Carcinoma

Status Completed

Clinical Trial Summary

This phase I trial studies the side effects and best dose of cixutumumab when given together with everolimus and octreotide acetate in treating patients with advanced low- or intermediate-grade neuroendocrine cancer. Monoclonal antibodies, such as cixutumumab, may find tumor cells and help carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide acetate may interfere with the growth of tumor cells and slow the growth of neuroendocrine cancer. Giving cixutumumab together with everolimus and octreotide acetate may be a better treatment for neuroendocrine cancer.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To recommend a phase 2 dose for the combination of IMC-A12 (cixutumumab) and everolimus, given with octreotide long-acting release (LAR) (octreotide acetate), in patients with advanced neuroendocrine tumors.

II. To describe the pharmacokinetics of IMC-A12 given once every 21 days in combination with everolimus and octreotide LAR.

III. To evaluate pharmacodynamic markers in blood, and tumor tissue.

SECONDARY OBJECTIVES:

I. To evaluate the safety profile of IMC-A12 and everolimus with octreotide LAR.

II. To explore the anti-tumor activity of the combination of IMC-A12 and everolimus as defined by Response Evaluation Criteria in Solid Tumors (RECIST) response rate and progression-free survival (PFS).

TERTIARY OBJECTIVES:

I. To explore baseline molecular marker and drug-induced molecular marker changes that may predict clinical outcome.

OUTLINE: This is a dose-escalation study of cixutumumab.

Patients receive cixutumumab intravenously (IV) over 60-90 minutes and octreotide acetate intramuscularly (IM) on day 1 and everolimus orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoma
• Carcinoma, Islet Cell
• Carcinoma, Merkel Cell
• Carcinoma, Neuroendocrine
• Gastrin-Producing Neuroendocrine Tumor
• Gastrinoma
• Gastrointestinal Neoplasms
• Glucagonoma
• Insulinoma
• Lung Carcinoid Tumor
• Malignant Carcinoid Syndrome
• Metastatic Digestive System Neuroendocrine Tumor G1
• Neuroendocrine Tumors
• Pancreatic Glucagonoma
• Pancreatic Insulinoma
• Pancreatic Polypeptide Tumor
• Paraganglioma
• Recurrent Digestive System Neuroendocrine Tumor G1
• Recurrent Merkel Cell Carcinoma
• Recurrent Pancreatic Neuroendocrine Carcinoma
• Regional Digestive System Neuroendocrine Tumor G1
• Somatostatin-Producing Neuroendocrine Tumor
• Somatostatinoma
• Stage III Merkel Cell Carcinoma
• Stage IV Merkel Cell Carcinoma
• Thyroid Gland Medullary Carcinoma
• Thyroid Neoplasms

• NCT number: NCT01204476
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 1
• Start date: October 2010