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Zalutumumab in Patients With Non-curable Head and Neck Cancer

Phase 3
Completed
Conditions
Head and Neck Cancer
Squamous Cell Cancer
Interventions
Other: Control
Registration Number
NCT00382031
Lead Sponsor
Genmab
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

Status
COMPLETED
Sex
All
Target Recruitment
286
Inclusion Criteria
  1. Males and Females age ≥ 18 years
  2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
  3. Failure to at least one course of standard platinum-based chemotherapy
Exclusion Criteria
  1. Three or more chemotherapy regimens other than platinum-based chemotherapy
  2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
  3. Past or current malignancy other than SCCHN, except for certain other cancer diseases

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
zalutumumabZalutumumabZalutumumab in combination with Best Supportive Care
zalutumumabControlZalutumumab in combination with Best Supportive Care
ControlControlBest Supportive Care
Primary Outcome Measures
NameTimeMethod
Overall SurvivalFrom 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
NameTimeMethod
Objective Tumor ResponseFrom 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 ResponseTime 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.

Trial Locations

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

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