Phase 2
N=110
Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00468169 ↗Enrolled (actual)
110
Serious AEs
19.1%
Results posted
Oct 2019
Primary outcome: Primary: Progression Free Survival (PFS) — 87.7; 92.5 Probability (%) — p=0.1225
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cetuximab (Drug); 5-FU (Drug); Hydroxyurea (Drug); Twice-daily radiation (Radiation); Cisplatin (Drug); Accelerated fraction radiotherapy with concomitant boost (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
82.5; 84.9 | — |
| PRIMARY Progression Free Survival (PFS) |
82.5; 84.9 | — |
| SECONDARY Overall Survival (OS) |
91.2; 94.3 | — |
| SECONDARY Objective Response Rate to Induction |
7; 4; 47; 41; 3; 7 | — |
| SECONDARY Objective Response Rate to CRT |
3; 4 | — |
| SECONDARY Residual Lymph Node Disease |
2; 6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00468169). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.