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

November 21, 2011 updated by: Genmab

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • St-Luc University Hospital
      • Leuven, Belgium
        • University Hospital Gasthuisberg
  • France
      • Dijon, France
        • Centre Georges-Francois Leclerc Hospital
      • Tours, France
        • Hopital Bretonneau Clinique d'Oncologie et Radiothérapie
  • Netherlands
      • Nijmegen, Netherlands
        • Nijmegen University Hospital
  • Sweden
      • Lund, Sweden
        • Lund University Hospital
  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Overall Study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 3 years
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
Up to 3 years
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
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genmab

Investigators

  • Principal Investigator: Vincent Gregoire, MD professor, St-Luc University Hospital, Brussels, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

November 17, 2006

First Submitted That Met QC Criteria

November 17, 2006

First Posted (Estimate)

November 20, 2006

Study Record Updates

Last Update Posted (Estimate)

December 23, 2011

Last Update Submitted That Met QC Criteria

November 21, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hx-EGFr-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe