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Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442)

A Phase II Study of Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck

NCT00343083•University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the response of the tumor to the treatment regimen that will be used in this study. This study will also test the safety of cetuximab (C225), given with chemotherapy and radiation therapy. We also want to see what effects (good and bad) cetuximab, chemotherapy, and radiation therapy have head \& neck cancer. C225 has been designed to stop the growth of the tumor by blocking certain chemical pathways that lead to tumor cell growth. In prior studies with head \& neck cancer patients, C225 has delayed tumor growth and provided relief of symptoms in some patients.

Detailed Description

Primary Objective- To evaluate whether the addition of Cetuximab (C225) in combination with chemotherapy and radiation can cause an enhanced anti-tumor effect resulting in improving local regional control of patients with locally advanced, unresectable squamous cell carcinoma of head and neck. (SCCHN). OVERVIEW OF STUDY DESIGN Open label, non-randomized, single arm trial. P = Paclitaxel will be administered on a weekly schedule at a dose of 40mg/m2 IV by 1-hour infusion prior to cetuximab dose. This will be administered for a total of 8 weeks (from weeks 2-9) C225 = Cetuximab: 400 mg/m2 IV will be given as the initial OR loading dose in week 1 and then 250 mg/m2 IV weekly will be given for 8 weeks (weeks 2-9). C = Carboplatin will be given at a dose of AUC=2/week - will be administered as a 30 minute infusion after cetuximab infusion (weeks 2-9) RT = Radiation therapy will be delivered at 1.8 Gy fraction/day, 5 days a week for a total of 70.2 Gy. RT will be given from weeks 2-9. Note: Sequence of administration will be paclitaxel followed by cetuximab followed by carboplatin followed by XRT. Approximately 60 patients from MSGCC/BVAMC will participate in this study. Prior to entering the study the doctor will examine the patient and order blood tests ( which will be done by blood draw, approximately 2 tablespoons) and tests to measure the patients disease (scans). The patient will also be evaluated by a dietician who will follow the patient throughout the course of the therapy to help the patient meet his/her nutritional needs

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically proved locally advanced squamous cell carcinoma of the head and neck of all primary sites. The following TNM stages by sites will be eligible.Oral cavity, Pharynx, Larynx, Nasopharynx, paranasal sinuses, Oral cavity, Pharynx, Larynx, Nasopharynx, paranasal sinuses- T4 N0 N1 N2-A,B,C N3, T3 N0 N1 N2-A,B,C N3 Any T N2-A,B,C N3 Unknown primary Tx N2-A,B,C N3 Note: Only clearly unresectable T4 N0 lesions are eligible for study provided the reasons for unresectability are due to extensive anatomic involvement and are outlined by the surgeon
•2. Patients must have signed an approved informed consent.
•3. Patients with Performance Status 0-2.
•4. No evidence of distant metastatic disease.
•5. No previous radiation therapy.
•6. No previous chemotherapy.
•7. Patients must be greater than 18 years of age.
•8. Women of child bearing potential (WOCBP) must have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
•9. Pretreatment evaluations include:
•History and physical examination within four weeks prior to study entry Dental evaluation Medical oncology examination to evaluate medical contraindications prior to start of chemotherapy
+4 more criteria

Exclusion Criteria

•Any of the following criteria will make the patient ineligible to participate in this study:
•1. Acute hepatitis or known HIV.
•2. Active or uncontrolled infection.
•3. Significant history of concomitant life threatening / uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and known cardiomyopathy with decreased ejection fraction, cardiac arrhythmia
•4. Prior therapy which specifically and directly targets the EGFR pathway.
•5. Prior severe infusion reaction to a monoclonal antibody.
•6. Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
•7. Women of childbearing potential (WOCBP) and male participants who are unwilling or unable to use an effective method to avoid pregnancy for the entire study period
•8. Preexisting clinically significant neuropathy.

Locations (1)

University of Maryland & Baltimore VA medical centre

Baltimore, Maryland, United States

Key Dates

Start Date

December 1, 2004

Primary Completion Date

June 1, 2011

Completion Date

May 1, 2012

Last Updated

August 19, 2019

Enrollment

ACTUAL participants

Conditions

Cancer of Head and Neck

Interventions

Erbitux, Paclitaxel & Carboplatin

DRUG

Radiation

RADIATION

Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma

NCT02296684

Cancer of Head and NeckHead and Neck Cancer+4 more

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COMPLETEDNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442)

Inclusion Criteria

Exclusion Criteria

Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma

RCT of Effects of Mindfulness-based Stress Reduction in Head and Neck Cancer

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