Zalutumumab in Patients With Non-curable Head and Neck Cancer

Phase 3

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
zalutumumab	Zalutumumab	Zalutumumab in combination with Best Supportive Care
zalutumumab	Control	Zalutumumab in combination with Best Supportive Care
Control	Control	Best Supportive Care

Primary Outcome Measures

Name	Time	Method
Overall Survival	From randomization until death	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.

Secondary Outcome Measures

Name	Time	Method
Objective Tumor Response	From date of randomization until the date of death from any cause, assessed up to 41 months.	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
Duration of Response	Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.	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.
Progression Free Survival (PFS)	From randomization until disease progression or death, assessed up to 41 months.	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.

Locations (82): University Hospital Antwerp
🇧🇪
Antwerp, Belgium
St-Luc University Hospital
🇧🇪
Brussels, Belgium
CHNDRF
🇧🇪
Charleroi, Belgium
"University Hospital
🇧🇪
Gent, Belgium
University Hospital Leuven
🇧🇪
Leuven, Belgium
Cliniques Saint Pierre
🇧🇪
Ottignies, Belgium
BioCancer
🇧🇷
Belo Horizonte, Brazil
Hospital Erasto Gaertner
🇧🇷
Curitiba, Brazil
Centro Goiano de Oncologia
🇧🇷
Goiânia, Brazil
Hospital Araújo Jorge
🇧🇷
Goiânia, Brazil
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University Hospital Antwerp
🇧🇪Antwerp, Belgium