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

NCT01204476 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-07-15

No results posted yet for this study

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.

Conditions

  • Gastrin-Producing Neuroendocrine Tumor
  • Lung Carcinoid Tumor
  • Metastatic Digestive System Neuroendocrine Tumor G1
  • 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
  • Stage III Merkel Cell Carcinoma
  • Stage IV Merkel Cell Carcinoma
  • Thyroid Gland Medullary Carcinoma

Interventions

BIOLOGICAL

Cixutumumab

Given IV

DRUG

Everolimus

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Octreotide Acetate

Given IM

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • James Yao · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01204476 on ClinicalTrials.gov