Phase 2
Completed N=33
Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Source: ClinicalTrials.gov NCT00971932 ↗Enrolled (actual)
33
Serious AEs
36.4%
Results posted
Aug 2012
Primary outcomePrimary: Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria — 36.4 percentage of participants
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 metastatic squamous cell carcinoma of the head and neck (SCCHN) in Japanese subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria |
36.4 | — |
| SECONDARY Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria |
45.5 | — |
| SECONDARY Disease Control Rate |
87.9 | — |
| SECONDARY Duration of Response |
2.8 | — |
| SECONDARY Progression-Free Survival (PFS) Time |
4.1 | — |
| SECONDARY Overall Survival (OS) Time |
12.8 | — |
| SECONDARY Time to Treatment Failure |
4.2 | — |
Eligibility Criteria
Inclusion Criteria
- 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 ( 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 = 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
Data sourced from ClinicalTrials.gov (NCT00971932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.