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

NCT01177956 | Completed Phase 3 Results DMC

• 1 other identifier: EMR62241_055
• Study Type: interventional
• Target: 73
• Locations: 2 countries
• Sites: 14

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

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)

Outcome Measures

Primary Outcomes (2)

• Best Overall Response (BOR) Until Cut-off Date 25 January 2011

  BOR: Percentage of participants experiencing a Complete Response (CR) (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (PR) (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified World Health Organization \[WHO\] criteria), divided by the number of participants belonging to intention to treat (ITT) or safety population.

  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

• Best Overall Response (BOR) Until Cut-off Date 15 November 2012

  BOR: Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified WHO criteria), divided by the number of participants belonging to ITT or safety population.

  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 (7)

• Overall Survival (OS) Time Until Cut-off Date 15 November 2012

  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

• Progression-free Survival (PFS) Time Until Cut-off Date 25 January 2011

  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

• Progression-free Survival (PFS) Time Until Cut-off Date 15 November 2012

  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

• Time to Progression (TTP) Until Cut-off Date 25 January 2011

  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

• Time to Progression (TTP) Until Cut-off Date 15 November 2012

  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

Study Arms (1)

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

EXPERIMENTAL

Biological: Cetuximab; Drug: Cisplatin; Drug: 5-Fluorouracil

Interventions

Cetuximab 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.

Also known as: Erbitux®

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

Cisplatin 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.

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

5-Fluorouracil 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (14)

Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Jilin Cancer Hospital

Changchun, China

Location

The Xiangya 2nd Hospital of Central South University

Changsha, China

Location

Fuijan Provincial Tumor Hospital

Fuijian, China

Location

Nanfang Hospital of Nanfang Medical University

Guangzhou, China

Location

Sun Yat-Sen Univesity Cancer Center

Guangzhou, China

Location

Zhejiang Provincial Tumor Hospital

Hangzhou, China

Location

Jiangsu Cancer Hospital

Jiangsu, Nanjing, China

Location

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

Nanning, China

Location

Eye & ENT Hospital of Fundan University

Shanghai, China

Location

Fundan University Shanghai Cancer Center

Shanghai, China

Location

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

Wuhan, China

Location

Xijing Hospital, the Fourth Military Medical University

Xi'an, China

Location

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

Busan, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24710768 RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cetuximab; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: August 9, 2010
• Study Start: December 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: November 1, 2012
• Last Updated: September 3, 2014
• Results First Posted: August 10, 2012

Record last verified: 2014-08

Locations

KR (1); CN (13)