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: July 5, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 10, 2009

Last Updated Date

July 5, 2012

Start Date ^ICMJE

February 2009

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Cancer radiology assessment [ Time Frame: Within 12 weeks after trial treatment since some subjects with CR or PR should have another confirmative assessment at least 28 days after the first crietra was met. ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01012258 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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).

Original Secondary Outcome Measures ^ICMJE

The survival time will be measured by frequent visits and survival status record. Progression-Free-Survival time will be measured by frequent radiology assessment until disease progression is observed or clinical progression is diagnosed. [ Time Frame: Variable for each subject ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Squamous Cell Carcinoma of the Head and Neck

Intervention ^ICMJE

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®

Study Arm (s)

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

Intervention: Biological: Cetuximab + concomitant boost radiotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

February 2014

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01012258

Other Study ID Numbers ^ICMJE

EMR62241-054

Has Data Monitoring Committee

Responsible Party

Merck KGaA

Study Sponsor ^ICMJE

Merck KGaA

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Merck KGaA

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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