Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer - Full Text View

Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer (EPIC)

This study is currently recruiting participants.

Verified by University of Chicago, June 2008

First Received: April 30, 2007 Last Updated: June 27, 2008 History of Changes

Sponsors and Collaborators:	University of Chicago Bristol-Myers Squibb
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00468169

Purpose

The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: Cetuximab	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Drug Information available for: Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase II Trial of Concurrent Chemoradiation With Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-Daily Radiation (CetuxFHX) Versus Cetuximab (ERBITUX®), Cisplatin, and Accelerated Radiation With Concomitant Boost (CetuxPX) After Induction Chemotherapy in Patients With Locally Advanced Head and Neck Cancer

Further study details as provided by University of Chicago:

Primary Outcome Measures:

progression free survival (PFS) and overall survival (OS) [ Time Frame: 1-year and 2-year progression free survival as well as overall survival ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

to assess and compare the toxicity profile of both regimens; to assess best overall response rate [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	110
Study Start Date:	July 2006
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental The chemotherapy with radiation will consist of a combination of two drugs, cisplatin and cetuximab	Drug: Cetuximab Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
2: Experimental The chemotherapy with radiation will consist of 5-FU, hydroxyurea and cetuximab	Drug: Cetuximab Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 or older
Stage III and IV head and neck cancer
Patients with squamous cell carcinoma of unknown primary and suspected origin in the head and neck area
No prior chemotherapy or radiotherapy
Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures only
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Normal organ and marrow function

Exclusion Criteria:

Unequivocal demonstration of metastatic disease
Known severe hypersensitivity to drugs used in the study
Treatment with a non-approved or investigational drug within 30 days before Day 1
Incomplete healing from previous surgery
Pregnancy or breast feeding
Uncontrolled intercurrent illness including
Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF
Acute hepatitis or known HIV
Severe baseline neurologic deficits
Prior therapy which specifically and directly targets the EGFR pathway
Prior severe infusion reaction to a monoclonal antibody

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468169

Contacts

Contact: Allison Dekker, R.N.	773-702-2068	adekker@medicine.bsd.uchicago.edu
Contact: Rosalyn Williams	773-702-0712	rwilliam@medicine.bsd.uchicago.edu

Locations

United States, Illinois
University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Contact: Allison Dekker, RN 773-702-2068 adekker@medicine.bsd.uchicago.edu
Contact: Rosalyn Williams 773-702-0712 rwilliam@medicine.bsd.uchicago.edu
Principal Investigator: Everett E Vokes, MD

Sponsors and Collaborators

University of Chicago

Bristol-Myers Squibb

Investigators

Principal Investigator:

Everett E Vokes, MD

University of Chicago

More Information

No publications provided

Responsible Party:	BMS ( Kelly J. Smith-Williams )
Study ID Numbers:	14401A
Study First Received:	April 30, 2007
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00468169 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by University of Chicago:

Cetuximab
Erbitux
locally
advanced
head
neck

cancer
neoplasms
squamous
carcinoma
lymphoepithelioma

Study placed in the following topic categories:

Cisplatin
Hydroxyurea
Fluorouracil

Head and Neck Neoplasms
Cetuximab
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses

Head and Neck Neoplasms
Cetuximab
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009