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

September 20, 2019 updated by: University of Chicago

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: Cetuximab+FHX
Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks.
Drug: Cetuximab
250mg/m2(day 1, weekly x 10);
Other Names:
  • Erbitux (R)
Drug: 5-FU
600 mg/m2/day; days 0-5 (120 h total) every other week x 5
Drug: Hydroxyurea
500 mg PO BID, days 0-5 every other week x 5
Radiation: Twice-daily radiation
150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)
Experimental: B: Cetuximab + PX
Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks.
Drug: Cetuximab
250mg/m2(day 1, weekly x 10);
Other Names:
  • Erbitux (R)
Drug: Cisplatin
100 mg/m2, week 1 and 4 on day 1 (or 2)
Radiation: Accelerated fraction radiotherapy with concomitant boost
72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 1 years
Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
1 years
Progression Free Survival (PFS)
Time Frame: 2 years
Time from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 2 years
Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years.
2 years
Objective Response Rate to Induction
Time Frame: Post-Induction (8 weeks)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Post-Induction (8 weeks)
Objective Response Rate to CRT
Time Frame: From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks
Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination.
From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks
Residual Lymph Node Disease
Time Frame: Up to 10 weeks
Response to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (>1.5 cm) or focally abnormal lymph node.
Up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Everett E Vokes, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

April 30, 2007

First Submitted That Met QC Criteria

May 1, 2007

First Posted (Estimate)

May 2, 2007

Study Record Updates

Last Update Posted (Actual)

October 9, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14401A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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