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

NCT ID: NCT01177956

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-11-30

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cetuximab + Cisplatin + 5-Fluorouracil (5-FU)

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: BIOLOGICAL

The initial dose of cetuximab will be 400 milligram per square meter (mg/m^2) as an intravenous (IV) infusion over 120 minutes. Subsequent weekly doses will be 250 mg/m^2 as an IV infusion over 60 minutes.

Chemotherapy will be continued for up to a maximum of six 3-week cycles in the absence of progressive disease (PD) or unacceptable toxicity. All subjects will receive cetuximab treatment until the occurrence of PD or unacceptable toxicity to cetuximab.

Cisplatin

Intervention Type: DRUG

Subjects will receive 75 mg/m\^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle.

5-Fluorouracil

Intervention Type: DRUG

Subjects will receive 750 mg/m\^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle.

Interventions

Cetuximab

The initial dose of cetuximab will be 400 milligram per square meter (mg/m^2) as an intravenous (IV) infusion over 120 minutes. Subsequent weekly doses will be 250 mg/m^2 as an IV infusion over 60 minutes.

Chemotherapy will be continued for up to a maximum of six 3-week cycles in the absence of progressive disease (PD) or unacceptable toxicity. All subjects will receive cetuximab treatment until the occurrence of PD or unacceptable toxicity to cetuximab.

Intervention Type: BIOLOGICAL

Cisplatin

Subjects will receive 75 mg/m\^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle.

Intervention Type: DRUG

5-Fluorouracil

Subjects will receive 750 mg/m\^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle.

Intervention Type: DRUG

Other Intervention Names

Erbitux®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Jilin Cancer Hospital

Changchun, , China

The Xiangya 2nd Hospital of Central South University

Changsha, , China

Fuijan Provincial Tumor Hospital

Fuijian, , China

Nanfang Hospital of Nanfang Medical University

Guangzhou, , China

Sun Yat-Sen Univesity Cancer Center

Guangzhou, , China

Zhejiang Provincial Tumor Hospital

Hangzhou, , China

Jiangsu Cancer Hospital

Jiangsu, Nanjing, , China

Tumor Hospital of Guangxi Zhuang Autonomous Region / The Tumor Affiliated Hospital of Guangxi Medical University

Nanning, , China

Eye & ENT Hospital of Fundan University

Shanghai, , China

Fundan University Shanghai Cancer Center

Shanghai, , China

Tongji Hospital of Tongji Medical College of Huazhong University of Science & Technology

Wuhan, , China

Xijing Hospital, the Fourth Military Medical University

Xi'an, , China

Clinical Trial Center of Medical Research Institute, Pusan National University Hospital

Busan, , South Korea

Countries

China; South Korea

References

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.

Reference Type: RESULT

PMID: 24710768 (View on PubMed)

Other Identifiers

EMR62241_055

Identifier Type: -

Identifier Source: org_study_id