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Carcinoma of the Head and NeckPhase 2NCT00865098

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

A Phase 2 study testing Cetuximab in people with Carcinoma of the Head and Neck, run by Merck KGaA, Darmstadt, Germany at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Carcinoma of the Head and Neck
What is being tested?
Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
4 sitesJapan
Study dates
Mar 2009to Jun 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • The patient is eligible if disease free from a previously treated malignancy for greater than three years.
  • The patient agrees to use effective contraception if procreative potential exists.
  • The patient has given signed informed consent
  • The patient who is a Japanese with Japanese citizenship

Who cannot join

  • 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.
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  • 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.
  • The patient has been received some investigational medication within 30 days before study entry.

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

  • Research Site

    Aichi

  • Research Site

    Chiba

  • Research Site

    Shizuoka

  • Research Site

    Tokyo

Other trials in Japan

About this study

Official title: Open-label, Non-randomized, Non-controlled, Multicenter Phase II Study Investigating Cetuximab in Combination With Concomitant-boost Radiotherapy as First-line Treatment for Japanese Patients With Newly Diagnosed Locally Advanced SCCHN.

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.

Being tested
Cetuximab
Keywords
Newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CetuximabDrug

    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.

Study groups in NCT00865098
Study groupRoleWhat they receive
Cetuximab With RadiotherapyExperimentalNot described
Receives: Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (5)

  1. Best Response Rate

    Number of subjects experiencing a Complete Response (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (>=50% decrease of the sum of the product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions) at 8 weeks post radiotherapy (confirmed by repeat assessment at week 12) based on imaging according to modified World Health Organisation criteria as assessed independently by the Efficacy and Safety Evaluation Committee, divided by the number of subjects in the ITT/safety population

    Measured: 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

  2. Safety - Number of Patients Experiencing Any Adverse Event

    Please refer to Adverse Events section for further details

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

  3. Safety - Number of Patients Experiencing Any Grade 4 Adverse Event

    Severity was assessed according to the toxicity criteria defined in the National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE), Version 3.0, where grade 1 denoted mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling. In the case of adverse events not contained within the NCI-CTCAE, the investigator was responsible for assessing the severity of the AE (grades 1 to 4) based on the jeopardy to the subject's health and well-being, and the ability of the subject to function during the event.

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

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

    Skin reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.

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

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

    Infusion related reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00865098
Sponsor's protocol ID
EMR 62241-053
Status last verified
Feb 2014
First submitted
18 Mar 2009
Last updated
12 Mar 2014

Publications

  • 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.

    PubMed 23479383

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab in people with Carcinoma of the Head and Neck, run by Merck KGaA, Darmstadt, Germany at 4 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion Rate (time frame: time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00865098, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2014.

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