Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer

Genmab

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Squamous Cell Cancer; Head and Neck Cancer

Treatments: Drug: cisplatin; Procedure: Radiotherapy; Drug: zalutumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401401

Hx-EGFr-203

Details and patient eligibility

About

The purpose of this study is to investigate the safety of zalutumumab in combination with chemotherapy and radiotherapy as treatment of patients with head and neck cancer

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx

Exclusion criteria

• Prior treatment with radiotherapy in the head and neck area
• Prior treatment with chemotherapy
• Prior treatment with similar drugs (e.g. EGFr antibodies, EGFr inhibitors)
• Previous surgery with curative intent for head and neck cancer

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 4 patient groups

Zalutumumab 4 mg/kg

Experimental group

Description:

Zalutumumab 8 weekly infusions

Treatment:

Procedure: Radiotherapy

Drug: zalutumumab

Drug: cisplatin

Zalutumumab 8 mg/kg

Experimental group

Description:

Zalutumumab 8 weekly infusions

Treatment:

Procedure: Radiotherapy

Drug: zalutumumab

Drug: cisplatin

Zalutumumab 12 mg/kg

Experimental group

Description:

Zalutumumab 8 weekly infusions

Treatment:

Procedure: Radiotherapy

Drug: zalutumumab

Drug: cisplatin

Zalutumumab 16 mg/kg

Experimental group

Description:

Zalutumumab 8 weekly infusions

Treatment:

Procedure: Radiotherapy

Drug: zalutumumab

Drug: cisplatin