Status:
COMPLETED
Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
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 m...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed diagnosis of SCCHN
- Confirmed epidermal growth factor receptor (EGFR) expression in tumor tissue by immunohistochemistry (IHC)
- Expected survival is more than 6 months
- Presence of at least 1 bidimensionally measurable lesion either by computed tomography (CT) scan or magnetic resonance imaging (MRI)
- Recurrent and/or metastatic SCCHN not suitable for local therapy
- Greater than or equal to (\>=) 20 years of age
- Karnofsky performance status (KPS) \>= 70% at trial entry
- Neutrophils: \>= 1500 per millimeter\^3 (1,500/mm\^3); platelet count \>= 100,000/mm\^3; and hemoglobin \>= 9 gram per deciliter (g/dL)
- Total bilirubin less than or equal to (\<=) 2 \* upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<= 3 \* ULN
- Creatinine clearance \>60 milliliter per minute (mL/min).Calculated based on formulae such as the Cockroft-Gault formula for creatinine clearance
- 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 \* \[actual serum albumin (g/dL) - 4\]
- Effective contraception if risk of conception exists (applicable for both male and female subjects)
- Signed written informed consent
- Japanese (with Japanese citizenship)
Exclusion
- Nasopharyngeal carcinoma
- Prior systemic chemotherapy, except if given as part of a multimodal treatment, which was completed more than 6 months prior to trial entry
- Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial entry
- Pregnancy (absence to be confirmed by serum/urine human chorionic gonadotropin \[HCG\] test) or breastfeeding
- Known hypersensitivity or allergic reaction against any of the components of the trial treatment including excipients
- 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
- Pulmonary fibrosis, acute lung injury or interstitial pneumonia, or with previous medical history of these states
- Active infection, (infection requiring IV antibiotics, antibacterial, antifungal, or antiviral agent), including active tuberculosis, or known and declared human immunodeficiency virus (HIV)
- 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
- 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
- Intake of any investigational medication within 30 days before trial entry
- Other concomitant anticancer therapies
- Documented or symptomatic brain or leptomeningeal metastasis
- Medical or psychological condition that would not permit the subject to complete the trial or sign informed consent including known drug abuse
- Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or EGFR targeting therapy
- Legal incapacity or limited legal capacity
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00971932
Start Date
July 1 2009
Last Update
April 8 2014
Active Locations (10)
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1
Research Site
Aichi, Japan
2
National Cancer Center East Hospital
Chiba, Japan
3
Research Site
Ehime, Japan
4
Research Site
Hokkaido, Japan