Cetuximab With Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects (CHANCE)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 3

Conditions: Squamous Cell Carcinoma of the Head and Neck

Treatments: Biological: Cetuximab + concomitant boost radiotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01012258

EMR62241-054

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 (<=) 2*upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3*ULN
• Serum creatinine <=133 micromole/liter (mcmol/L)
• Serum calcium within normal range
• Effective contraception if procreative potential exists (applicable to both male and female subjects)
• Chinese with Chinese citizenship
• Signed written informed consent

Exclusion criteria

• Evidence of distant metastatic disease
• Squamous cell carcinoma arising in the nasopharynx or oral cavity
• Receipt of prior systemic chemotherapy within the last 3 years
• Previous surgery for the tumor under study other than biopsy
• Receipt of prior RT to the head and neck
• Currently receiving RT as part of a postoperative regimen following primary surgical resection
• Planned neck dissection after trial RT
• Active infection (infection requiring IV antibiotics), including active tuberculosis, or known and declared human immunodeficiency virus (HIV)
• Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, cardiac failure or liver failure
• Uncontrolled hypertension defined as systolic blood pressure >=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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Cetuximab

Experimental group

Description:

All eligible subjects will receive cetuximab treatment only during week 1 of the treatment course and concomitant cetuximab and boost radiotherapy (RT) during week two to week seven of the treatment course

Treatment:

Biological: Cetuximab + concomitant boost radiotherapy