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

The University of Chicago

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: 5-FU; Drug: Hydroxyurea; Drug: Cisplatin; Radiation: Twice-daily radiation; Drug: Cetuximab; Radiation: Accelerated fraction radiotherapy with concomitant boost

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00468169

14401A

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

A: Cetuximab+FHX

Experimental group

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.

Treatment:

Drug: Cetuximab

Radiation: Twice-daily radiation

Drug: Hydroxyurea

Drug: 5-FU

B: Cetuximab + PX

Experimental group

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.

Treatment:

Drug: Cetuximab

Drug: Cisplatin

Radiation: Accelerated fraction radiotherapy with concomitant boost