Clinical trial NCT01177956: A Trial to Determine the Safety and Anti-tumor Activity Profile of the Combination of Cetuximab and Concomitant Cisplatin Plus 5-Fluorouracil (5-FU) in Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma in Head and Neck
Official title: Open-label, Single-arm, Multicenter, Phase III Trial to Assess the Antitumor Activity and Safety Profile of Cetuximab When Given in Combination With Chemotherapy for the First-line Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck in Asian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Recurrent and/or metastatic squamous cell carcinoma of the head and neck
1st-line
Cetuximab
Chemotherapy
EMR 62241 -055
Merck KGaA
Recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN)
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-08-09
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to assess the antitumor activity and safety profile of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic Squamous Cell Carcinoma in Head and Neck (SCCHN) in Asian subjects.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Inpatient
* Greater than or equal to (\>=) 18 years of age
* Histologically or cytologically confirmed diagnosis of SCCHN
* Recurrent and/or metastatic SCCHN not suitable for local therapy
* Presence of at least 1 measurable lesion identified either by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified WHO criteria
* Karnofsky performance status (KPS) \>= 80 percent at trial entry
* Neutrophils \>= 1.5\*10\^9 per liter (L), platelet count \>= 100\*10\^9 per L, and hemoglobin \>= 90 gram per 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 per liter (mcmol/L)
* Serum calcium within normal range
* Effective contraception if procreative potential exists (applicable for both male and female subjects)

Exclusion Criteria:

* Prior systemic chemotherapy, except if given as part of a multimodal treatment which was completed more than 6 months prior to trial entry
* Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial entry
* Nasopharyngeal carcinoma
* 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
* Medical or psychological condition that would not permit the subject to complete the trial or sign informed consent
* Known drug abuse (with the exception of alcohol abuse)
* Known hypersensitivity or allergic reaction against any of the components of the trial treatment
* Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or epidermal growth factor receptor (EGFR) targeting therapy
* Previous or current other squamous cell carcinoma (SCC)
* Evidence of previous other malignancy within the last 5 years
* Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such
* Intake of any investigational medication within 30 days before trial entry
* Legal incapacity or limited legal capacity
* Other significant disease that in the Investigator's opinion would exclude the subject from the trial

Primary outcomes:
measure: Best Overall Response (BOR) Until Cut-off Date 25 January 2011
timeFrame: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011
measure: Best Overall Response (BOR) Until Cut-off Date 15 November 2012
timeFrame: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012
Secondary outcomes:
measure: Overall Survival (OS) Time Until Cut-off Date 15 November 2012
timeFrame: Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012
measure: Progression-free Survival (PFS) Time Until Cut-off Date 25 January 2011
timeFrame: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011
measure: Progression-free Survival (PFS) Time Until Cut-off Date 15 November 2012
timeFrame: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012
measure: Time to Progression (TTP) Until Cut-off Date 25 January 2011
timeFrame: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011
measure: Time to Progression (TTP) Until Cut-off Date 15 November 2012
timeFrame: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012
measure: Duration of Response Until Cut-off Date 25 January 2011
timeFrame: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011
measure: Duration of Response Until Cut-off Date 15 November 2012
timeFrame: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute & Hospital, Chinese Academy of Medical Sciences
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Changsha City
country: China
facility: The Xiangya 2nd Hospital of Central South University
city: Fuijian
country: China
facility: Fuijan Provincial Tumor Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital of Nanfang Medical University
city: Guangzhou
country: China
facility: Sun Yat-Sen Univesity Cancer Center
city: Hangzhou
country: China
facility: Zhejiang Provincial Tumor Hospital
city: Jiangsu, Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Nanning City
country: China
facility: Tumor Hospital of Guangxi Zhuang Autonomous Region / The Tumor Affiliated Hospital of Guangxi Medical University
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fundan University
city: Shanghai
country: China
facility: Fundan University Shanghai Cancer Center
city: Wuhan City
country: China
facility: Tongji Hospital of Tongji Medical College of Huazhong University of Science & Technology
city: Xi'an
country: China
facility: Xijing Hospital, the Fourth Military Medical University
city: Busan
country: Korea, Republic of
facility: Clinical Trial Center of Medical Research Institute, Pusan National University Hospital
Study officials:
References:
citation: Guo Y, Shi M, Yang A, Feng J, Zhu X, Choi YJ, Hu G, Pan J, Hu C, Luo R, Zhang Y, Zhou L, Cheng Y, Lupfert C, Cai J, Shi Y. Platinum-based chemotherapy plus cetuximab first-line for Asian patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: Results of an open-label, single-arm, multicenter trial. Head Neck. 2015 Aug;37(8):1081-7. doi: 10.1002/hed.23707. Epub 2014 Sep 17.