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

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ClinicalTrials.gov Identifier: NCT00401401
Recruitment Status : 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.)
First Posted : November 20, 2006
Results First Posted : December 23, 2011
Last Update Posted : December 23, 2011
Sponsor:
Information provided by (Responsible Party):
Genmab

Brief Summary:
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 or disease Intervention/treatment Phase
Head and Neck Cancer Squamous Cell Cancer Drug: zalutumumab Drug: cisplatin Procedure: Radiotherapy Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : December 2006
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT00401401     History of Changes
Other Study ID Numbers: Hx-EGFr-203
First Posted: November 20, 2006    Key Record Dates
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