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Phase 1 Trial With SIR-Spheres and Cetuximab +/- Erlotinib

NCT01432119 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-04-09

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of selective internal radiation (SIR)-Spheres with yttrium-90 attached and cetuximab. Some participants will also take erlotinib with this combination.

Yttrium-90 microspheres are designed to treat cancer that has spread to the liver. SIR-Spheres are designed to deliver the radiation directly to the liver. This radiation may cause the tumor cells to die.

Cetuximab and erlotinib are drugs that are designed to block the epidermal growth factor receptor (EGFR). EGFR is a protein that helps cancer cells grow. Blocking the EGFR may stop tumors from growing.

Conditions

Interventions

DEVICE

SIR-Spheres

100% full dose SIR-Spheres on Day 1 of Cycle 1. SIR-Spheres with yttrium-90 microspheres will be given through a catheter in a vein in the groin.

DRUG

Cetuximab

Starting Dose: 200 mg/m2 by vein weekly. During Cycle 1, patients will receive cetuximab during Weeks 2-4. In Cycles 2 and beyond, patients will receive cetuximab weekly.

DRUG

Erlotinib

Starting dose: 100 mg by mouth daily. Erlotinib will be given starting with Cycle 2 at 100 mg by mouth daily. If tolerated, the dose will be increased to 150 mg by mouth daily in Cycle 3.

PROCEDURE

Break-Through Scan

Nuclear medicine "break-through" scan performed within 29 days before receiving SIR-Spheres. The results of this test will be used to determine if a full or partial dose of SIR-Spheres with yttrium-90 microspheres will be delivered.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Aung Naing, MD · UT MD Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2019-12-31

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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 NCT01432119 on ClinicalTrials.gov