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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01012258
First received: November 10, 2009
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Squamous Cell Carcinoma of the Head and Neck
Biological: Cetuximab + concomitant boost radiotherapy
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Baseline up to disease progression or withdrawal or 12 weeks after the last radiotherapy of the last participant ] [ Designated as safety issue: No ]
    Progression-free survival was defined as the duration (in months) from first administration of trial treatment to first observation of PD (radiological or clinical, if radiological PD is not available), or death due to any cause. The PFS time of participants without observation of PD but death occurring after two or more missed consecutive tumor assessments (i.e. two-fold scheduled time interval of two consecutive tumor assessments) was censored on the date of last tumor assessment or first administration of trial treatment (whichever was later).


Enrollment: 70
Study Start Date: February 2009
Estimated Study Completion Date: April 2014
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Biological: 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 Name: Erbitux®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012258

Locations
China, Fujian
Fujian Provincial Tumor Hospital
Fuzhou, Fujian, China
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
Sponsors and Collaborators
Merck KGaA
Investigators
Principal Investigator: Li Gao Radiotherapy Department, Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, China
Study Director: Junliang Cai Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd., an Affiliate of Merck KGaA, Darmstadt, Germany
Principal Investigator: Guozhen Xu Radiotherapy Department, Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, China
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01012258     History of Changes
Other Study ID Numbers: EMR62241-054
Study First Received: November 10, 2009
Results First Received: July 5, 2012
Last Updated: January 20, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Merck KGaA:
antitumor activity
safety
cetuximab in combination with radiotherapy
locally advanced squamous cell head & neck carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Cetuximab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014