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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by University of Chicago.
Recruitment status was:  Active, not recruiting
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
  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:


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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 02, 2016