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Completed

NCT Number: NCT00382031

Zalutumumab in Patients With Non-curable Head and Neck Cancer

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

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Antwerp, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zalutumumab

Drug

Individual dose titration weekly i.v doses

Other names: Zalutumumab in combination with Best Supportive Care

Control

Other

Best Supportive Care

Other names: Best Supportive Care

Primary outcomes

  1. Overall Survival

    Time frame: 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 outcomes

  1. Objective Tumor Response

    Time frame: 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

  2. Duration of Response

    Time frame: 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.

  3. Progression Free Survival (PFS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Genmab

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2011
First posted
Sep 28, 2006
Registry last updated
Oct 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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