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

NCT01012258 | Completed Phase 3 Results

• 1 other identifier: EMR62241-054
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 8

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.

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

Outcome Measures

Primary Outcomes (1)

• Best Overall Response (BOR)

  Best overall (objective) response was defined as the occurrence of complete response (CR) or partial response (PR) based on the investigator's assessment according to modified World Health Organization (WHO) criteria confirmed at a repeat assessment performed no less than 28 days after the criteria for response were first met. CR was defined as disappearance of all index lesions. PR was defined as a 50% or more decrease in the sum of the products of diameters (SOPD) of index lesions compared to the baseline SOPD, with no evidence of PD.

  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 (1)

• Progression-Free Survival (PFS)

  Baseline up to disease progression or withdrawal or 12 weeks after the last radiotherapy of the last participant

Study Arms (1)

Cetuximab

EXPERIMENTAL

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

Biological: Cetuximab + concomitant boost radiotherapy

Interventions

Cetuximab + concomitant boost radiotherapy BIOLOGICAL

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

Also known as: Erbitux®

Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (8)

Fujian Provincial Tumor Hospital

Fuzhou, Fujian, China

Location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

Zhejiang Provincial Cancer Hospital

Hangzhou, China

Location

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Responsible
• Organization: Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd.

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Li Gao

  Radiotherapy Department, Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, China

  PRINCIPAL INVESTIGATOR

• Junliang Cai

  Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd., an Affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

• Guozhen Xu

  Radiotherapy Department, Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, China

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 13, 2009
• Study Start: February 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: May 1, 2014
• Last Updated: July 9, 2015
• Results First Posted: August 14, 2012

Record last verified: 2015-06

Locations

CN (8)