Zalutumumab in Patients With Non-curable Head and Neck Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open-Labeled Randomized Parallel Group Trial of Zalutumumab, a Human Monoclonal Anti-EGFr Antibody, in Combination With Best Supportive Care (BSC) vs BSC, in Pts With Non-Curable SCCHN Who Have Failed Standard Platinum-Based Chemotherapy

Conditions
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Head and Neck Cancer, Squamous Cell Cancer

Intervention / Treatment
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* Drug: Zalutumumab
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and Females age ≥ 18 years Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy Failure to at least one course of standard platinum-based chemotherapy Exclusion Criteria: Three or more chemotherapy regimens other than platinum-based chemotherapy Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors Past or current malignancy other than SCCHN, except for certain other cancer diseases

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: zalutumumab<br>Zalutumumab in combination with Best Supportive Care | Drug: Zalutumumab<br>* Individual dose titration weekly i.v doses<br>* Other names: Zalutumumab in combination with Best Supportive Care;Other: Control<br>* Best Supportive Care<br>* Other names: Best Supportive Care;|
| Other: Control<br>Best Supportive Care | Other: Control<br>* Best Supportive Care<br>* Other names: Best Supportive Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | A patient's overall survival was defined as the time from the date of randomization until the date of death from any cause, assessed up to 41 months. Overall survival was censored if the patient was lost to follow-up or refused to continue in the trial. | From randomization until death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Tumor Response | Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0) 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 | From date of randomization until the date of death from any cause, assessed up to 41 months. | 
| Duration of Response | Duration of response defined as the time from the first date where measurement criteria for complete or partial response (whichever status is recorded first) are met until the first date that death, recurrence or progressive disease is objectively documented. | Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months. | 
| Progression Free Survival (PFS) | PFS (defined as the time from randomization until disease progression or death). The progression events were defined by well-documented and verifiable imaging data. In case of censoring, the date of censoring had to be the last time point documenting the status of the patient. | From randomization until disease progression or death, assessed up to 41 months. |