Phase 3
N=68
A Trial to Determine the Safety and Anti-tumor Activity Profile of the Combination of Cetuximab and Concomitant Cisplatin Plus 5-Fluorouracil (5-FU) in Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma in Head and Neck
Squamous Cell Carcinoma of the Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT01177956 ↗Enrolled (actual)
68
Serious AEs
13.0%
Results posted
Aug 2012
Primary outcome: Primary: Best Overall Response (BOR) Until Cut-off Date 25 January 2011 — 54.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cetuximab (Biological); Cisplatin (Drug); 5-Fluorouracil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response (BOR) Until Cut-off Date 25 January 2011 |
54.4 | — |
| PRIMARY Best Overall Response (BOR) Until Cut-off Date 15 November 2012 |
55.9 | — |
| SECONDARY Overall Survival (OS) Time Until Cut-off Date 15 November 2012 |
12.6 | — |
| SECONDARY Progression-free Survival (PFS) Time Until Cut-off Date 25 January 2011 |
6.2 | — |
| SECONDARY Progression-free Survival (PFS) Time Until Cut-off Date 15 November 2012 |
6.6 | — |
| SECONDARY Time to Progression (TTP) Until Cut-off Date 25 January 2011 |
6.8 | — |
| SECONDARY Time to Progression (TTP) Until Cut-off Date 15 November 2012 |
7.0 | — |
| SECONDARY Duration of Response Until Cut-off Date 25 January 2011 |
5.7 | — |
| SECONDARY Duration of Response Until Cut-off Date 15 November 2012 |
6.1 | — |
Summary
The primary objective of this trial is to assess the antitumor activity and safety profile 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 in Head and Neck (SCCHN) in Asian subjects.
Eligibility Criteria
Inclusion Criteria
- Signed written informed consent
- Inpatient
- Greater than or equal to (>=) 18 years of age
- Histologically or cytologically confirmed diagnosis of SCCHN
- Recurrent and/or metastatic SCCHN not suitable for local therapy
- Presence of at least 1 measurable lesion identified either by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified WHO criteria
- Karnofsky performance status (KPS) >= 80 percent at trial entry
- Neutrophils >= 1.5*10^9 per liter (L), platelet count >= 100*10^9 per L, and hemoglobin >= 90 gram per liter (g/L)
- Total bilirubin less than or equal to ( =180 millimeter of mercury (mmHg) and/or diastolic blood pressure >=130 mmHg under resting conditions
- Pregnancy (absence to be confirmed by serum beta human chorionic gonadotrophin [beta-HCG] test) or breastfeeding
- Concomitant chronic systemic immune therapy or hormonal therapy as cancer therapy
- Other concomitant anticancer therapies
- Documented or symptomatic brain or leptomeningeal metastasis
- 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
- Medical or psychological condition that would not permit the subject to complete the trial or sign informed consent
- Known drug abuse (with the exception of alcohol abuse)
- Known hypersensitivity or allergic reaction against any of the components of the trial treatment
- Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or epidermal growth factor receptor (EGFR) targeting therapy
- Previous or current other squamous cell carcinoma (SCC)
- Evidence of previous other malignancy within the last 5 years
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such
- Intake of any investigational medication within 30 days before trial entry
- Legal incapacity or limited legal capacity
- Other significant disease that in the Investigator's opinion would exclude the subject from the trial
Data sourced from ClinicalTrials.gov (NCT01177956). 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.