Know Cancer

forgot password

Open-label, Single-arm, Multicenter, Phase II Study Investigating Cetuximab in Combination With Chemotherapy in the First-line Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) in Japanese Subjects

Phase 2
20 Years
Open (Enrolling)
Squamous Cell Carcinoma of the Head and Neck

Thank you

Trial Information

Open-label, Single-arm, Multicenter, Phase II Study Investigating Cetuximab in Combination With Chemotherapy in the First-line Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) in Japanese Subjects

Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of SCCHN

2. Confirmed epidermal growth factor receptor (EGFR) expression in tumor tissue by
immunohistochemistry (IHC)

3. Expected survival is more than 6 months

4. Presence of at least 1 bidimensionally measurable lesion either by computed
tomography (CT) scan or magnetic resonance imaging (MRI)

5. Recurrent and/or metastatic SCCHN not suitable for local therapy

6. Greater than or equal to (>=) 20 years of age

7. Karnofsky performance status (KPS) >= 70% at trial entry

8. Neutrophils: >= 1500 per millimeter^3 (1,500/mm^3); platelet count >= 100,000/mm^3;
and hemoglobin >= 9 gram per deciliter (g/dL)

9. Total bilirubin less than or equal to (<=) 2 * upper limit of normal (ULN); aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 * ULN

10. Creatinine clearance >60 milliliter per minute (mL/min).Calculated based on formulae
such as the Cockroft-Gault formula for creatinine clearance

11. 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]

12. Effective contraception if risk of conception exists (applicable for both male and
female subjects)

13. Signed written informed consent

14. Japanese (with Japanese citizenship)

Exclusion Criteria:

1. Nasopharyngeal carcinoma

2. Prior systemic chemotherapy, except if given as part of a multimodal treatment, which
was completed more than 6 months prior to trial entry

3. Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before
trial entry

4. Pregnancy (absence to be confirmed by serum/urine human chorionic gonadotropin [HCG]
test) or breastfeeding

5. Known hypersensitivity or allergic reaction against any of the components of the
trial treatment including excipients

6. 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

7. Pulmonary fibrosis, acute lung injury or interstitial pneumonia, or with previous
medical history of these states

8. Active infection, (infection requiring IV antibiotics, antibacterial, antifungal, or
antiviral agent), including active tuberculosis, or known and declared human
immunodeficiency virus (HIV)

9. Clinically relevant coronary artery disease or history of myocardial infarction in
the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac

10. 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

11. Intake of any investigational medication within 30 days before trial entry

12. Other concomitant anticancer therapies

13. Documented or symptomatic brain or leptomeningeal metastasis

14. Medical or psychological condition that would not permit the subject to complete the
trial or sign informed consent including known drug abuse

15. Previous treatment with monoclonal antibody therapy, other signal transduction
inhibitors or EGFR targeting therapy

16. Legal incapacity or limited legal capacity

17. Other protocol-defined exclusion criteria may apply

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Description:

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).

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Mark P. Smith, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merck Serono Co., Ltd., Japan


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

EMR 62241-056



Start Date:

July 2009

Completion Date:

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Recurrent and/or metastatic
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms