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

Head and Neck Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468169
• Other study ID #: 14401A
• Status: Completed
• Phase: Phase 2
• Start date: July 2006
• Est. completion date: November 2012

Study information

• Verified date: September 2019
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Cetuximab
250mg/m2(day 1, weekly x 10);
• 5-FU
600 mg/m2/day; days 0-5 (120 h total) every other week x 5
• 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)

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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 years
Primary	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.	2 years
Secondary	Overall Survival (OS)	Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years.	2 years
Secondary	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.	Post-Induction (8 weeks)
Secondary	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.	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
Secondary	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.	Up to 10 weeks