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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Everett Vokes, University of Chicago
ClinicalTrials.gov Identifier:
NCT00468169
First received: April 30, 2007
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Cetuximab
U.S. FDA Resources

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: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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)
Experimental: 2
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

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
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: Everett Vokes, Chairman, Department of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT00468169     History of Changes
Other Study ID Numbers: 14401A
Study First Received: April 30, 2007
Last Updated: October 5, 2012
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cetuximab
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013