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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.


Phase 2
20 Years
N/A
Not Enrolling
Both
Carcinoma of the Head and Neck

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Trial Information

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.


Inclusion Criteria:



1. The patient has pathologically proven squamous cell carcinoma arising in the
oropharynx, hypopharynx, or larynx.

2. The patient has been confirmed Epidermal Growth Factor Receptor expressing in tumor
specimen by immunohistochemistry.

3. 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.

4. The patient has at least bi-dimensionally measurable disease.

5. The patient is medically suitable to withstand a course of the definitive radiation
therapy.

6. The patient aged ≥ 20 years old at informed consent

7. The patient's Karnofsky performance status is ≥ 60

8. Hemoglobin ≥ 9g/dL

9. Neutrophil ≥ 1500/mm^3

10. Platelet ≥ 100,000/mm^3

11. Total Bilirubin ≤ 1.5 mg/dL

12. Aspartate Aminotransferase ≤ 2 x the upper limit of normal

13. Alanine Aminotransferase ≤ 2 x the upper limit of normal

14. Serum creatinine ≤ 1.5 mg/dL

15. Serum calcium concentration: within normality

16. The patient is eligible if disease free from a previously treated malignancy for
greater than three years.

17. The patient agrees to use effective contraception if procreative potential exists.

18. The patient has given signed informed consent

19. The patient who is a Japanese with Japanese citizenship

Exclusion Criteria:

1. 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.

2. The patient has squamous cell carcinoma arising in the nasopharynx or oral cavity.

3. The patient has received prior systemic chemotherapy within the last three years.

4. The patient has undergone previous surgery for the tumor under study other than
biopsy.

5. The patient has received prior radiation therapy to the head and neck.

6. The patient's radiation therapy is considered to be a part of a postoperative regimen
following primary surgical resection.

7. The patient is pregnant or breast feeding.

8. 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.

9. 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).

10. The patient has uncontrolled diabetes mellitus, malignant hypertension, or liver
failure.

11. The patient has or has suffered from a pulmonary fibrosis, acute pulmonary disorder,
or interstitial pneumonia.

12. 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.

13. 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

14. The patient has a dental disease which requires incision and drainage.

15. 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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Completion Rate

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Masataka Ota, MD

Investigator Role:

Study Director

Investigator Affiliation:

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

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

EMR 62241-053

NCT ID:

NCT00865098

Start Date:

March 2009

Completion Date:

June 2010

Related Keywords:

  • Carcinoma of the Head and Neck
  • Newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN)
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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