Clinical trial NCT01012258: Cetuximab With Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: antitumor activity
safety
cetuximab in combination with radiotherapy
locally advanced squamous cell head & neck carcinoma
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 (\<=) 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

Primary outcomes:
measure: Best Overall Response (BOR)
timeFrame: 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:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline up to disease progression or withdrawal or 12 weeks after the last radiotherapy of the last participant
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Tumor Hospital
state: Fujian
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
city: Changsha, Hunan
country: China
facility: Xiangya Hospital of Central South University
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Hangzhou
country: China
facility: Zhejiang Provincial Cancer Hospital
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
city: Wuhan, Hubei
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
city: Wuhan, Hubei
country: China
facility: Zhongnan Hospital of Wuhan University
Study officials:
affiliation: Radiotherapy Department, Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, China
name: Li Gao
role: PRINCIPAL_INVESTIGATOR
affiliation: Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd., an Affiliate of Merck KGaA, Darmstadt, Germany
name: Junliang Cai
role: STUDY_DIRECTOR
affiliation: Radiotherapy Department, Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, China
name: Guozhen Xu
role: PRINCIPAL_INVESTIGATOR
References: