Phase 3
N=66
Cetuximab With Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects
Squamous Cell Carcinoma of the Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT01012258 ↗Enrolled (actual)
66
Serious AEs
14.8%
Results posted
Aug 2012
Primary outcome: Primary: Best Overall Response (BOR) — 68.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cetuximab + concomitant boost radiotherapy (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response (BOR) |
68.2 | — |
| SECONDARY Progression-Free Survival (PFS) |
9.4 | — |
Summary
Primary objective: to assess the antitumor activity and safety profile of cetuximab when given in combination with radiotherapy (RT) for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in Chinese subjects.
Secondary objective: to assess the pharmacokinetic (PK) profile and immunogenicity of cetuximab in Chinese subjects.
Further objective: to identify for cetuximab potential predictive biomarkers of response and safety.
Eligibility Criteria
Inclusion Criteria
- Inpatient greater than or equal to (>=) 18 years of age
- Pathologically proven squamous cell carcinoma arising in the oropharynx, hypopharynx or larynx
- Stage III or IV disease with an expected survival of at least 12 months
- Medically suitable to withstand a course of concomitant boost RT
- Presence of at least 1 bi-dimensionally measurable lesion identified either by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified World Health Organization (WHO) criteria
- Karnofsky Performance Status (KPS) >=80 at trial entry
- Neutrophils >=1.5*10^9/Liter (L), platelet count >= 100*10^9/L, hemoglobin >= 90 gram/liter (g/L)
- Total bilirubin less than or equal to ( =180 millimeter of mercury (mmHg) and/or diastolic blood pressure >=130 mmHg under resting conditions
- Pregnancy (absence to be confirmed by serum beta human chorionic gonadotrophin [beta-HCG] test) or breastfeeding
- Concomitant chronic systemic immune therapy or hormonal therapy as cancer therapy
- Other concomitant anticancer therapies
- Documented or symptomatic brain or leptomeningeal metastasis
- Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
- Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or epidermal growth factor receptor (EGFR) targeting therapy
- Evidence of previous other malignancy within the last 5 years
- Intake of any investigational medication within 30 days before trial entry
- Other protocol-defined exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01012258). 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.