Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

NCT00971932 | Completed Phase 2 Results DMC

• 1 other identifier: EMR 62241-056
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 10

Brief Summary

The primary objective of this trial is to assess the antitumor activity 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 of the head and neck (SCCHN) in Japanese subjects.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

Recurrent and/or metastatic; SCCHN

Outcome Measures

Primary Outcomes (1)

• Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria

  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 in the sum of the products of diameters \[SOPD\] of index lesions compared to the baseline SOPD, with no evidence of PD) confirmed by a subsequent assessment no less than 28 days after criteria for response were first met based on modified WHO criteria as assessed by Independent Review Committee (IRC).

  Evaluations performed every 6 weeks until progressive disease (PD) reported between day of first participant treated, until cut-off date, 02 March 2011

Secondary Outcomes (6)

• Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

  Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011

• Disease Control Rate

  Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011

• Duration of Response

  Time from first assessment of CR or PR to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011

• Progression-Free Survival (PFS) Time

  Time from first administration of trial treatment to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011

• Overall Survival (OS) Time

  Time from first administration of trial treatment or last day known to be alive, reported between day of first participant treated, until cut-off date, 02 March 2011

Study Arms (1)

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

EXPERIMENTAL

Drug: Cetuximab; Drug: Cisplatin/Carboplatin; Drug: 5-Fluorouracil

Interventions

Cetuximab DRUG

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.

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

Cisplatin/Carboplatin DRUG

Subjects will receive 100 mg/m\^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle. If subject developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) will be administered as an IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.

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

5-Fluorouracil DRUG

Subjects will receive 1000 mg/m\^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle.

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of SCCHN
• Confirmed epidermal growth factor receptor (EGFR) expression in tumor tissue by immunohistochemistry (IHC)
• Expected survival is more than 6 months
• Presence of at least 1 bidimensionally measurable lesion either by computed tomography (CT) scan or magnetic resonance imaging (MRI)
• Recurrent and/or metastatic SCCHN not suitable for local therapy
• Greater than or equal to (\>=) 20 years of age
• Karnofsky performance status (KPS) \>= 70% at trial entry
• Neutrophils: \>= 1500 per millimeter\^3 (1,500/mm\^3); platelet count \>= 100,000/mm\^3; and hemoglobin \>= 9 gram per deciliter (g/dL)
• Total bilirubin less than or equal to (\<=) 2 \* upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<= 3 \* ULN
• Creatinine clearance \>60 milliliter per minute (mL/min).Calculated based on formulae such as the Cockroft-Gault formula for creatinine clearance
• Serum calcium within normal range (If serum albumin \< 4.0 g/dL, the following adjusted serum calcium concentration should be within normality: Adjusted serum calcium concentration = actual serum calcium (milligram per deciliter \[mg/dL\]) - 0.8 \* \[actual serum albumin (g/dL) - 4\]
• Effective contraception if risk of conception exists (applicable for both male and female subjects)
• Signed written informed consent
• Japanese (with Japanese citizenship)

You may not qualify if:

• Nasopharyngeal carcinoma
• 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
• Pregnancy (absence to be confirmed by serum/urine human chorionic gonadotropin \[HCG\] test) or breastfeeding
• Known hypersensitivity or allergic reaction against any of the components of the trial treatment including excipients
• Uncontrolled diabetes, malignant hypertension (defined as systolic blood pressure \>= 180 millimeter of mercury \[mmHg\] and/or diastolic blood pressure \>= 130 mmHg under resting conditions) or liver failure
• Pulmonary fibrosis, acute lung injury or interstitial pneumonia, or with previous medical history of these states
• Active infection, (infection requiring IV antibiotics, antibacterial, antifungal, or antiviral agent), including active tuberculosis, or known and declared human immunodeficiency virus (HIV)
• 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
• Current other squamous cell carcinoma (SCC) or previous other malignancy (excluding skin cancer except for melanoma and carcinoma in situ of the cervix or digestive tract) within the last 5 years
• Intake of any investigational medication within 30 days before trial entry
• Other concomitant anticancer therapies
• Documented or symptomatic brain or leptomeningeal metastasis
• Medical or psychological condition that would not permit the subject to complete the trial or sign informed consent including known drug abuse
• Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or EGFR targeting therapy

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (10)

Research Site

Aichi, Japan

Location

National Cancer Center East Hospital

Chiba, Japan

Location

Research Site

Ehime, Japan

Location

Research Site

Hokkaido, Japan

Location

Research Site

Kanagawa, Japan

Location

Tokai University

Kanagawa, Japan

Location

Research Site

Osaka, Japan

Location

Research Site

Shizuoka, Japan

Location

Research Site

Tochigi, Japan

Location

Research Site

Tokyo, Japan

Location

Related Publications (1)

• Yoshino T, Hasegawa Y, Takahashi S, Monden N, Homma A, Okami K, Onozawa Y, Fujii M, Taguchi T, de Blas B, Beier F, Tahara M. Platinum-based chemotherapy plus cetuximab for the first-line treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: results of a phase II trial. Jpn J Clin Oncol. 2013 May;43(5):524-31. doi: 10.1093/jjco/hyt034. Epub 2013 Mar 10.

  PMID: 23479384 RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cetuximab; Cisplatin; Carboplatin; 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; Coordination Complexes; Organic Chemicals; 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

Study Officials

• Mark P. Smith, MD

  Merck Serono Co., Ltd., Japan

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 4, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2011
• Last Updated: April 8, 2014
• Results First Posted: August 10, 2012

Record last verified: 2014-03

Locations

JP (10)