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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cetuximab
5-FU
Hydroxyurea
Twice-daily radiation
Cisplatin
Accelerated fraction radiotherapy with concomitant boost
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Cetuximab, Erbitux, locally, advanced, head, neck, cancer, neoplasms, squamous, carcinoma, lymphoepithelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A: Cetuximab+FHX

B: Cetuximab + PX

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
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.
Progression Free Survival (PFS)
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.

Secondary Outcome Measures

Overall Survival (OS)
Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years.
Objective Response Rate to Induction
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.
Objective Response Rate to CRT
Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination.
Residual Lymph Node Disease
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.

Full Information

First Posted
April 30, 2007
Last Updated
September 20, 2019
Sponsor
University of Chicago
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00468169
Brief Title
Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
Acronym
EPIC
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Cetuximab, Erbitux, locally, advanced, head, neck, cancer, neoplasms, squamous, carcinoma, lymphoepithelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: Cetuximab+FHX
Arm Type
Experimental
Arm Description
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.
Arm Title
B: Cetuximab + PX
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux (R)
Intervention Description
250mg/m2(day 1, weekly x 10);
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
600 mg/m2/day; days 0-5 (120 h total) every other week x 5
Intervention Type
Drug
Intervention Name(s)
Hydroxyurea
Intervention Description
500 mg PO BID, days 0-5 every other week x 5
Intervention Type
Radiation
Intervention Name(s)
Twice-daily radiation
Intervention Description
150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
100 mg/m2, week 1 and 4 on day 1 (or 2)
Intervention Type
Radiation
Intervention Name(s)
Accelerated fraction radiotherapy with concomitant boost
Intervention Description
72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
1 years
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years.
Time Frame
2 years
Title
Objective Response Rate to Induction
Description
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.
Time Frame
Post-Induction (8 weeks)
Title
Objective Response Rate to CRT
Description
Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination.
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
Title
Residual Lymph Node Disease
Description
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.
Time Frame
Up to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Everett E Vokes, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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