Study of Cetuximab With Concomitant-boost Radiotherapy in Patients With Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

NCT00865098 | Completed Phase 2 Results

• 1 other identifier: EMR 62241-053
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

Brief Summary

This study is conducted in Japanese newly diagnosed locally advanced SCCHN patients in order to assess tolerability and feasibility of Cetuximab plus concomitant boost radiotherapy (RT) regimen (the study treatment) and its safety profile (i.e. AEs: adverse events). In addition, efficacy (i.e. anti-tumor effect) of the study treatment is also evaluated.

Conditions

Carcinoma of the Head and Neck

Keywords

Newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN)

Outcome Measures

Primary Outcomes (1)

• Completion Rate

  Number of subjects who complete ≥70% of Cetuximab planned dose administration in terms of relative dose intensity of Cetuximab and full dose of RT ≤2 weeks over planned schedule in terms of RT duration ≤8 weeks, divided by the the number of subjects in the ITT/Safety population

  time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeks

Secondary Outcomes (5)

• Best Response Rate

  best response was determined at week 8 post radiotherapy, for subjects with complete or partial response a confirmation in week 12 post radiotherapy was required

• Safety - Number of Patients Experiencing Any Adverse Event

  time from first dose up to 60 days after last dose of study treatment, ≤18 weeks

• Safety - Number of Patients Experiencing Any Grade 4 Adverse Event

  time from first dose up to 60 days after last dose of study treatment, ≤18 weeks

• Safety - Number of Patients Experiencing Any Grade 3 or 4 Skin Reaction

  time from first dose up to 60 days after last dose of study treatment, ≤18 weeks

• Safety - Number of Patients Experiencing Any Grade 3 or 4 Infusion Related Reaction

  time from first dose up to 60 days after last dose of study treatment, ≤18 weeks

Study Arms (1)

Cetuximab With Radiotherapy

EXPERIMENTAL

Drug: Cetuximab

Interventions

Cetuximab DRUG

Patients receive Cetuximab at an initial dose of 400 mg/m\^2 of Cetuximab to be infused 6 or 7 days before starting radiotherapy, followed by subsequent weekly infusions at a dose of 250 mg/m\^2 of Cetuximab and RT (72.0 Gy total in 42 fractions) for the next 6 weeks of the treatment course. Subjects will receive Cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of Cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with Cetuximab monotherapy every 7 days is continued.

Cetuximab With Radiotherapy

Eligibility Criteria

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

You may qualify if:

• The patient has pathologically proven squamous cell carcinoma arising in the oropharynx, hypopharynx, or larynx.
• The patient has been confirmed Epidermal Growth Factor Receptor expressing in tumor specimen by immunohistochemistry.
• The patient has stage III or IV disease (Unio Internationalis Contra Cancrum / International Union against Cancer Tumor-Lymph Nodes-Metastases classification) with an expected survival of ≥ 12 months.
• The patient has at least bi-dimensionally measurable disease.
• The patient is medically suitable to withstand a course of the definitive radiation therapy.
• The patient aged ≥ 20 years old at informed consent
• The patient's Karnofsky performance status is ≥ 60
• Hemoglobin ≥ 9g/dL
• Neutrophil ≥ 1500/mm\^3
• Platelet ≥ 100,000/mm\^3
• Total Bilirubin ≤ 1.5 mg/dL
• Aspartate Aminotransferase ≤ 2 x the upper limit of normal
• Alanine Aminotransferase ≤ 2 x the upper limit of normal
• Serum creatinine ≤ 1.5 mg/dL
• Serum calcium concentration: within normality

You may not qualify if:

• The patient has evidence of distant metastatic disease. The patient who has any metastatic disease documented by Magnetic Resonance Imaging for the head and neck, and Computed Tomography for the chest and abdomen should be excluded.
• The patient has squamous cell carcinoma arising in the nasopharynx or oral cavity.
• The patient has received prior systemic chemotherapy within the last three years.
• The patient has undergone previous surgery for the tumor under study other than biopsy.
• The patient has received prior radiation therapy to the head and neck.
• The patient's radiation therapy is considered to be a part of a postoperative regimen following primary surgical resection.
• The patient is pregnant or breast feeding.
• The patient has received prior Cetuximab or murine monoclonal antibody (including chimeric antibody) therapy or a history of severe hypersensitivity to any component of Cetuximab solution for Injection.
• The patient has a medical or psychological condition that would not permit the patient to complete the study or sign informed consent (including drug abuse).
• The patient has uncontrolled diabetes mellitus, malignant hypertension, or liver failure.
• The patient has or has suffered from a pulmonary fibrosis, acute pulmonary disorder, or interstitial pneumonia.
• The patient has an active infection (infection requiring intravenous anti-bacterial, anti-fungus, or anti-viral agent), or known and declared Human Immunodeficiency Virus infection.
• The patient has a 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
• The patient has a dental disease which requires incision and drainage.
• The patient has active multiple cancers (excluding skin cancer except for melanoma, and carcinoma in situ of the cervix or the digestive tract) in the last 3 years.

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (4)

Research Site

Aichi, Japan

Location

Research Site

Chiba, Japan

Location

Research Site

Shizuoka, Japan

Location

Research Site

Tokyo, Japan

Location

Related Publications (1)

• Okano S, Yoshino T, Fujii M, Onozawa Y, Kodaira T, Fujii H, Akimoto T, Ishikura S, Oguchi M, Zenda S, de Blas B, Tahara M, Beier F. Phase II study of cetuximab plus concomitant boost radiotherapy in Japanese patients with locally advanced squamous cell carcinoma of the head and neck. Jpn J Clin Oncol. 2013 May;43(5):476-82. doi: 10.1093/jjco/hyt030. Epub 2013 Mar 10.

  PMID: 23479383 RESULT

MeSH Terms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Masataka Ota
• Organization: Merck Serono Co., Ltd, Tokyo, Japan

+81 0 3 6853 8611

Study Officials

• Masataka Ota, MD

  Merck Serono Co.,Ltd, an Affilate of Merck Serono, Darmstadt, Germany

  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

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: March 19, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 12, 2014
• Results First Posted: July 22, 2011

Record last verified: 2014-02

Locations

JP (4)