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

Study Overview
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Brief Summary
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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

Official Title
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An Open-labeled Trial With a Dose-escalation Part and a Parallel Group Design(1) Investigating Zalutumumab, an Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation as First Line Treatment of Patients With Cancer of the Head and Neck (1) The Parallel Group Part Was Cancelled

Conditions
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Head and Neck Cancer, Squamous Cell Cancer

Intervention / Treatment
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* Drug: zalutumumab
* Drug: cisplatin
* Procedure: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zalutumumab 4 mg/kg<br>Zalutumumab 8 weekly infusions | Drug: zalutumumab<br>* Eight weekly infusions<br>Drug: cisplatin<br>* Infusions<br>Procedure: Radiotherapy<br>* Daily in the treatment period<br>|
| Experimental: Zalutumumab 8 mg/kg<br>Zalutumumab 8 weekly infusions | Drug: zalutumumab<br>* Eight weekly infusions<br>Drug: cisplatin<br>* Infusions<br>Procedure: Radiotherapy<br>* Daily in the treatment period<br>|
| Experimental: Zalutumumab 12 mg/kg<br>Zalutumumab 8 weekly infusions | Drug: zalutumumab<br>* Eight weekly infusions<br>Drug: cisplatin<br>* Infusions<br>Procedure: Radiotherapy<br>* Daily in the treatment period<br>|
| Experimental: Zalutumumab 16 mg/kg<br>Zalutumumab 8 weekly infusions | Drug: zalutumumab<br>* Eight weekly infusions<br>Drug: cisplatin<br>* Infusions<br>Procedure: Radiotherapy<br>* Daily in the treatment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial. | Overall Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response | Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR | Up to 3 years | 
| Time to Response | Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR | Up to 3 years | 
| Best Overall Tumor Response | Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR | Up to 3 years |