This trial is active, not recruiting.

Condition squamous cell carcinoma of the head and neck
Treatment cetuximab + concomitant boost radiotherapy
Phase phase 3
Sponsor Merck KGaA
Start date February 2009
End date September 2010
Trial size 70 participants
Trial identifier NCT01012258, EMR62241-054


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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
cetuximab + concomitant boost radiotherapy Erbitux®
Cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially Once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by Twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses are separated by at least a 6-hour interval

Primary Outcomes

Best Overall Response (BOR)
time frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 3 months following the 8 weeks after the end of RT visit until the end of trial (EOT) visit

Secondary Outcomes

Progression-Free Survival (PFS)
time frame: Baseline up to disease progression or withdrawal or 12 weeks after the last radiotherapy of the last participant

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Open-label, Single-arm, Multicenter, Phase III Trial to Assess the Antitumor Activity and Safety of Cetuximab When Given in Combination With Radiotherapy for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects
Principal investigator Li Gao
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Merck KGaA.