Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Recurrent and/or metastatic squamous cell carcinoma of the head and neck 1st-line Cetuximab Chemotherapy EMR 62241 -055 Merck KGaA Recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 73
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Cetuximab intervention 2: Cisplatin intervention 3: 5-Fluorouracil
Intervention descriptions: intervention 1: 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.

Chemotherapy will be continued for up to a maximum of six 3-week cycles in the absence of progressive disease (PD) or unacceptable toxicity. All subjects will receive cetuximab treatment until the occurrence of PD or unacceptable toxicity to cetuximab. intervention 2: Subjects will receive 75 mg/m\^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle. intervention 3: Subjects will receive 750 mg/m\^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle.

Protocol document: