Cetuximab With Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects
NCT ID: NCT01012258
Last Updated: 2015-07-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
70 participants
INTERVENTIONAL
2009-02-28
2014-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cetuximab
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
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
Interventions
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Cetuximab + concomitant boost radiotherapy
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Li Gao
Role: PRINCIPAL_INVESTIGATOR
Radiotherapy Department, Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, China
Junliang Cai
Role: STUDY_DIRECTOR
Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd., an Affiliate of Merck KGaA, Darmstadt, Germany
Guozhen Xu
Role: PRINCIPAL_INVESTIGATOR
Radiotherapy Department, Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, China
Locations
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Fujian Provincial Tumor Hospital
Fuzhou, Fujian, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Xiangya Hospital of Central South University
Changsha, Hunan, , China
Sun Yat-sen University Cancer Center
Guangzhou, , China
Zhejiang Provincial Cancer Hospital
Hangzhou, , China
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, , China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, , China
Countries
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Other Identifiers
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EMR62241-054
Identifier Type: -
Identifier Source: org_study_id
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