Phase 3
Completed N=442
Cetuximab (Erbitux) in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (EXTREME)
Source: ClinicalTrials.gov NCT00122460 ↗Enrolled (actual)
442
Serious AEs
48.9%
Results posted
Sep 2011
Primary outcomePrimary: Overall Survival Time (OS) — 10.1; 7.4 months — p=0.036
Summary
The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic head and neck cancer. Overall survival will be taken as the primary measure of efficacy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival Time (OS) |
10.1; 7.4 | 0.036 sig |
| SECONDARY Progression-free Survival Time (PFS) |
5.6; 3.3 | <0.0001 sig |
| SECONDARY Best Overall Response |
35.6; 19.5 | 0.0001 sig |
| SECONDARY Disease Control |
81.1; 60.0 | <0.0001 sig |
| SECONDARY Time to Treatment Failure |
4.8; 3.0 | <0.0001 sig |
| SECONDARY Duration of Response |
5.6; 4.7 | 0.21 |
| SECONDARY Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status |
50.74; 45.15; 52.68; 45.48; 55.30; 42.49 | — |
| SECONDARY Quality of Life Assessment (EORTC QLQ-C30) Social Functioning |
62.14; 62.05; 64.64; 60.67; 61.27; 65.72 | — |
| SECONDARY Safety - Number of Patients Experiencing Any Adverse Event |
218; 208 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN)
- Recurrent and/or metastatic SCCHN, not suitable for local therapy
Exclusion Criteria
- Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry
- Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry
- Nasopharyngeal carcinoma
Data sourced from ClinicalTrials.gov (NCT00122460). 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. Informational only — not medical advice.