Zalutumumab in Patients With Non-curable Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT00382031
First received: September 27, 2006
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Head and Neck Cancer
Squamous Cell Cancer
Drug: Zalutumumab
Other: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Genmab:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From randomization until death ] [ Designated as safety issue: No ]
    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:
  • Objective Tumor Response [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 41 months. ] [ Designated as safety issue: No ]
    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 Frame: Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months. ] [ Designated as safety issue: No ]
    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) [ Time Frame: From randomization until disease progression or death, assessed up to 41 months. ] [ Designated as safety issue: No ]
    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.


Enrollment: 286
Study Start Date: November 2006
Study Completion Date: August 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: zalutumumab
Zalutumumab in combination with Best Supportive Care
Drug: Zalutumumab
Individual dose titration weekly i.v doses
Other Name: Zalutumumab in combination with Best Supportive Care
Other: Control
Best Supportive Care
Other Name: Best Supportive Care
Control
Best Supportive Care
Other: Control
Best Supportive Care
Other Name: Best Supportive Care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382031

  Show 82 Study Locations
Sponsors and Collaborators
Genmab
Investigators
Study Chair: . Dept. of Medical Oncology, Cliniques Universitaires Saint-Luc Université Catholique de Louvain, Brussels, Belgium
  More Information

No publications provided by Genmab

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT00382031     History of Changes
Other Study ID Numbers: Hx-EGFr-202
Study First Received: September 27, 2006
Results First Received: May 28, 2013
Last Updated: August 9, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Sweden: Medical Products Agency
Romania: National Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
Poland: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Estonia: The State Agency of Medicine
Bulgaria: Ministry of Health
Canada: Health Canada

Additional relevant MeSH terms:
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Neoplasms by Site
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014