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Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer

This study has been terminated.
(MTD was established and patients completed 16 months safety f-up and response assessments. It is considered of limited value to follow patients for 3 years.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00401401
First Posted: November 20, 2006
Last Update Posted: December 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genmab
  Purpose
The purpose of this study is to investigate the safety of zalutumumab in combination with chemotherapy and radiotherapy as treatment of patients with head and neck cancer

Condition Intervention Phase
Head and Neck Cancer Squamous Cell Cancer Drug: zalutumumab Drug: cisplatin Procedure: Radiotherapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-labeled Trial With a Dose-escalation Part and a Parallel Group Design(1) Investigating Zalutumumab, an Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation as First Line Treatment of Patients With Cancer of the Head and Neck (1) The Parallel Group Part Was Cancelled

Resource links provided by NLM:


Further study details as provided by Genmab:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Overall Study ]
    Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial.


Secondary Outcome Measures:
  • Overall Response [ Time Frame: Up to 3 years ]
    Tumour response according to RECIST criteria 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

  • Time to Response [ Time Frame: Up to 3 years ]
    Tumour response according to RECIST criteria 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

  • Best Overall Tumor Response [ Time Frame: Up to 3 years ]
    Tumour response according to RECIST criteria 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


Enrollment: 30
Study Start Date: December 2006
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zalutumumab 4 mg/kg
Zalutumumab 8 weekly infusions
Drug: zalutumumab
Eight weekly infusions
Drug: cisplatin
Infusions
Procedure: Radiotherapy
Daily in the treatment period
Experimental: Zalutumumab 8 mg/kg
Zalutumumab 8 weekly infusions
Drug: zalutumumab
Eight weekly infusions
Drug: cisplatin
Infusions
Procedure: Radiotherapy
Daily in the treatment period
Experimental: Zalutumumab 12 mg/kg
Zalutumumab 8 weekly infusions
Drug: zalutumumab
Eight weekly infusions
Drug: cisplatin
Infusions
Procedure: Radiotherapy
Daily in the treatment period
Experimental: Zalutumumab 16 mg/kg
Zalutumumab 8 weekly infusions
Drug: zalutumumab
Eight weekly infusions
Drug: cisplatin
Infusions
Procedure: Radiotherapy
Daily in the treatment period

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx

Exclusion Criteria:

  • Prior treatment with radiotherapy in the head and neck area
  • Prior treatment with chemotherapy
  • Prior treatment with similar drugs (e.g. EGFr antibodies, EGFr inhibitors)
  • Previous surgery with curative intent for head and neck cancer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401401


Locations
United States, Oregon
Oregon Health Sciences Center
Portland, Oregon, United States, 97239
Belgium
St-Luc University Hospital
Brussels, Belgium
University Hospital Gasthuisberg
Leuven, Belgium
France
Centre Georges-Francois Leclerc Hospital
Dijon, France
Hopital Bretonneau Clinique d'Oncologie et Radiothérapie
Tours, France
Netherlands
Nijmegen University Hospital
Nijmegen, Netherlands
Sweden
Lund University Hospital
Lund, Sweden
Sponsors and Collaborators
Genmab
Investigators
Principal Investigator: Vincent Gregoire, MD professor St-Luc University Hospital, Brussels, Belgium
  More Information

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT00401401     History of Changes
Other Study ID Numbers: Hx-EGFr-203
First Submitted: November 17, 2006
First Posted: November 20, 2006
Results First Submitted: October 7, 2011
Results First Posted: December 23, 2011
Last Update Posted: December 23, 2011
Last Verified: November 2011

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