Phase 2 N=33 Treatment

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

Squamous Cell Carcinoma of the Head and Neck

Bottom Line

View on ClinicalTrials.gov: NCT00971932 ↗

Enrolled (actual)

Serious AEs

36.4%

Results posted

Aug 2012

Primary outcome: Primary: Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria — 36.4 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cetuximab (Drug); Cisplatin/Carboplatin (Drug); 5-Fluorouracil (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Merck KGaA, Darmstadt, Germany
Primary completion: Mar 2011

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	—

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.

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

View full record on ClinicalTrials.gov →

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.