Conditions: Head and Neck Cancer Squamous Cell Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 286
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer

Detailed description:
This is an open parallel group trial. Patients will be randomized in a 2:1 manner to receive either treatment with zalutumumab in combination with Best Supportive Care (BSC) or BSC.

Patients randomized to treatment with zalutumumab in combination with BSC will receive weekly infusions with zalutumumab starting with a loading dose (8mg/kg) followed by weekly maintenance doses until disease progression, intercurrent illness preventing further administration, unacceptable toxicity or patient decision. After Visit 2 the patient should be evaluated for presence of skin rash prior to each infusion to allow dose titration.

Individual dose titration until the patient develops grade 2 skin rash will be applied. The maximum dose used in study will be 16 mg/kg.

Arms:
arm 1: Zalutumumab in combination with Best Supportive Care arm 2: Best Supportive Care

Interventions: intervention 1: Zalutumumab intervention 2: Control
Intervention descriptions: intervention 1: Individual dose titration weekly i.v doses intervention 2: Best Supportive Care

Protocol document: