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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Squamous Cell Carcinoma of the Head and Neck

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

Cetuximab

Intervention Type 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.

Cisplatin/Carboplatin

Intervention Type 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.

5-Fluorouracil

Intervention Type 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.

Interventions

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Cetuximab

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.

Intervention Type DRUG

Cisplatin/Carboplatin

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.

Intervention Type DRUG

5-Fluorouracil

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.

Intervention Type DRUG

Eligibility Criteria

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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 insufficiency
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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No