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

Phase 1

Terminated

• Conditions: Squamous Cell Cancer; Head and Neck Cancer
• Interventions: Drug: zalutumumab; Drug: cisplatin; Procedure: Radiotherapy

• Registration Number: NCT00401401
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-17
• Study First Submitted QC: 2006-11-17
• Study First Posted: 2006-11-20
• Study Start: 2006-12
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2011-10-07
• Status Verified: 2011-11
• Results First Submitted QC: 2011-11-21
• Last Update Submitted: 2011-11-21
• Results First Posted: 2011-12-23
• Last Update Posted: 2011-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zalutumumab 4 mg/kg	Radiotherapy	Zalutumumab 8 weekly infusions
Zalutumumab 8 mg/kg	Radiotherapy	Zalutumumab 8 weekly infusions
Zalutumumab 12 mg/kg	Radiotherapy	Zalutumumab 8 weekly infusions
Zalutumumab 16 mg/kg	Radiotherapy	Zalutumumab 8 weekly infusions
Zalutumumab 4 mg/kg	cisplatin	Zalutumumab 8 weekly infusions
Zalutumumab 8 mg/kg	cisplatin	Zalutumumab 8 weekly infusions
Zalutumumab 12 mg/kg	cisplatin	Zalutumumab 8 weekly infusions
Zalutumumab 16 mg/kg	cisplatin	Zalutumumab 8 weekly infusions
Zalutumumab 8 mg/kg	zalutumumab	Zalutumumab 8 weekly infusions
Zalutumumab 4 mg/kg	zalutumumab	Zalutumumab 8 weekly infusions
Zalutumumab 12 mg/kg	zalutumumab	Zalutumumab 8 weekly infusions
Zalutumumab 16 mg/kg	zalutumumab	Zalutumumab 8 weekly infusions

Primary Outcome Measures

Name	Time	Method
Adverse Events	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

Name	Time	Method
Overall Response	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
Time to Response	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
Best Overall Tumor Response	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

Trial Locations

Locations (7)

Nijmegen University Hospital; 🇳🇱 Nijmegen, Netherlands

Lund University Hospital; 🇸🇪 Lund, Sweden

Centre Georges-Francois Leclerc Hospital; 🇫🇷 Dijon, France

Hopital Bretonneau Clinique d'Oncologie et Radiothérapie; 🇫🇷 Tours, France

University Hospital Gasthuisberg; 🇧🇪 Leuven, Belgium

Oregon Health Sciences Center; 🇺🇸 Portland, Oregon, United States

St-Luc University Hospital; 🇧🇪 Brussels, Belgium