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Preoperative Treatment With Cetuximab and/or IMC-A12

NCT00957853 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-03-19

Study results available
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Summary

The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may cause changes in biomarkers. Biomarkers are chemical "markers" in the blood and/or tissue that may be related to a reaction to study treatment.

The safety of the study treatments will also be studied.

Conditions

Interventions

DRUG

Cetuximab

First dose of 400 mg/m\^2 by vein on Days 1 and 8 over 2 hours, second dose of 250 mg/m\^2 on week 2 and 3 (if applicable) given over 1 hour.

DRUG

IMC-A12

6 mg/kg/week by vein on Days 1 and 8 over 1 hour on weeks 1 and 2 and 3 (if applicable).

PROCEDURE

Surgical tumor resection

Surgical tumor resection on Day 10.

Sponsors & Collaborators

Principal Investigators

  • Maura Gillison, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-17
Primary Completion
2018-08-15
Completion
2018-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00957853 on ClinicalTrials.gov