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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:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT00401401
First received: November 17, 2006
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  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: 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:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by Genmab:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Overall Study ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT00401401     History of Changes
Other Study ID Numbers: Hx-EGFr-203
Study First Received: November 17, 2006
Results First Received: October 7, 2011
Last Updated: November 21, 2011
Health Authority: United States: Food and Drug Administration
Sweden: Medical Products Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
 Cisplatin
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunologic Factors

ClinicalTrials.gov processed this record on June 13, 2013