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

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Cetuximab + concomitant boost radiotherapy
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck focused on measuring antitumor activity, safety, cetuximab in combination with radiotherapy, locally advanced squamous cell head & neck carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fujian Provincial Tumor Hospital
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Xiangya Hospital of Central South University
  • Sun Yat-sen University Cancer Center
  • Zhejiang Provincial Cancer Hospital
  • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Zhongnan Hospital of Wuhan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetuximab

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression-Free Survival (PFS)
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).

Full Information

First Posted
November 10, 2009
Last Updated
June 11, 2015
Sponsor
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01012258
Brief Title
Cetuximab With Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects
Acronym
CHANCE
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

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck
Keywords
antitumor activity, safety, cetuximab in combination with radiotherapy, locally advanced squamous cell head & neck carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetuximab
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Cetuximab + concomitant boost radiotherapy
Other Intervention Name(s)
Erbitux®
Intervention Description
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 Outcome Measure Information:
Title
Best Overall Response (BOR)
Description
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.
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 Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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).
Time Frame
Baseline up to disease progression or withdrawal or 12 weeks after the last radiotherapy of the last participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Gao
Organizational Affiliation
Radiotherapy Department, Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Junliang Cai
Organizational Affiliation
Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd., an Affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Guozhen Xu
Organizational Affiliation
Radiotherapy Department, Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Provincial Tumor Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
Facility Name
Xiangya Hospital of Central South University
City
Changsha, Hunan
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
Country
China
Facility Name
Zhejiang Provincial Cancer Hospital
City
Hangzhou
Country
China
Facility Name
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Facility Name
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan, Hubei
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan, Hubei
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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