Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer
NCT ID: NCT00401401
Last Updated: 2011-12-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2006-12-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Zalutumumab 4 mg/kg
Zalutumumab 8 weekly infusions
zalutumumab
Eight weekly infusions
cisplatin
Infusions
Radiotherapy
Daily in the treatment period
Zalutumumab 8 mg/kg
Zalutumumab 8 weekly infusions
zalutumumab
Eight weekly infusions
cisplatin
Infusions
Radiotherapy
Daily in the treatment period
Zalutumumab 12 mg/kg
Zalutumumab 8 weekly infusions
zalutumumab
Eight weekly infusions
cisplatin
Infusions
Radiotherapy
Daily in the treatment period
Zalutumumab 16 mg/kg
Zalutumumab 8 weekly infusions
zalutumumab
Eight weekly infusions
cisplatin
Infusions
Radiotherapy
Daily in the treatment period
Interventions
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zalutumumab
Eight weekly infusions
cisplatin
Infusions
Radiotherapy
Daily in the treatment period
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Genmab
INDUSTRY
Responsible Party
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Principal Investigators
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Vincent Gregoire, MD professor
Role: PRINCIPAL_INVESTIGATOR
St-Luc University Hospital, Brussels, Belgium
Locations
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Oregon Health Sciences Center
Portland, Oregon, United States
St-Luc University Hospital
Brussels, , Belgium
University Hospital Gasthuisberg
Leuven, , Belgium
Centre Georges-Francois Leclerc Hospital
Dijon, , France
Hopital Bretonneau Clinique d'Oncologie et Radiothérapie
Tours, , France
Nijmegen University Hospital
Nijmegen, , Netherlands
Lund University Hospital
Lund, , Sweden
Countries
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Other Identifiers
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Hx-EGFr-203
Identifier Type: -
Identifier Source: org_study_id