Back to resultsZalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer
Primary Purpose
Head and Neck Cancer, Squamous Cell Cancer
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
zalutumumab
cisplatin
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility 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
Sites / Locations
- Oregon Health Sciences Center
- St-Luc University Hospital
- University Hospital Gasthuisberg
- Centre Georges-Francois Leclerc Hospital
- Hopital Bretonneau Clinique d'Oncologie et Radiothérapie
- Nijmegen University Hospital
- Lund University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Zalutumumab 4 mg/kg
Zalutumumab 8 mg/kg
Zalutumumab 12 mg/kg
Zalutumumab 16 mg/kg
Arm Description
Zalutumumab 8 weekly infusions
Zalutumumab 8 weekly infusions
Zalutumumab 8 weekly infusions
Zalutumumab 8 weekly infusions
Outcomes
Primary Outcome Measures
Adverse Events
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00401401
Brief Title
Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
December 2006 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genmab
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Squamous Cell Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zalutumumab 4 mg/kg
Arm Type
Experimental
Arm Description
Zalutumumab 8 weekly infusions
Arm Title
Zalutumumab 8 mg/kg
Arm Type
Experimental
Arm Description
Zalutumumab 8 weekly infusions
Arm Title
Zalutumumab 12 mg/kg
Arm Type
Experimental
Arm Description
Zalutumumab 8 weekly infusions
Arm Title
Zalutumumab 16 mg/kg
Arm Type
Experimental
Arm Description
Zalutumumab 8 weekly infusions
Intervention Type
Drug
Intervention Name(s)
zalutumumab
Intervention Description
Eight weekly infusions
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Infusions
Intervention Type
Procedure
Intervention Name(s)
Radiotherapy
Intervention Description
Daily in the treatment period
Primary Outcome Measure Information:
Title
Adverse Events
Description
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.
Time Frame
Overall Study
Secondary Outcome Measure Information:
Title
Overall Response
Description
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 Frame
Up to 3 years
Title
Time to Response
Description
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 Frame
Up to 3 years
Title
Best Overall Tumor Response
Description
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 Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Gregoire, MD professor
Organizational Affiliation
St-Luc University Hospital, Brussels, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health Sciences Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
St-Luc University Hospital
City
Brussels
Country
Belgium
Facility Name
University Hospital Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Centre Georges-Francois Leclerc Hospital
City
Dijon
Country
France
Facility Name
Hopital Bretonneau Clinique d'Oncologie et Radiothérapie
City
Tours
Country
France
Facility Name
Nijmegen University Hospital
City
Nijmegen
Country
Netherlands
Facility Name
Lund University Hospital
City
Lund
Country
Sweden
12. IPD Sharing Statement
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Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer
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