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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00401401
• Other study ID #: Hx-EGFr-203
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: November 17, 2006
• Last updated: November 21, 2011
• Start date: December 2006
• Est. completion date: October 2010

Study information

• Verified date: November 2011
• Source: Genmab
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSweden: Medical Products AgencyBelgium: Federal Agency for Medicines and Health Products, FAMHPNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms
• Neoplasms, Squamous Cell
• Squamous Cell Cancer

Intervention

Drug:
• zalutumumab
Eight weekly infusions
• cisplatin
Infusions

Procedure:
• Radiotherapy
Daily in the treatment period

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Genmab

Countries where clinical trial is conducted

United States,  Belgium,  France,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Overall Study	Yes
Secondary	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	Up to 3 years	No
Secondary	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	Up to 3 years	No
Secondary	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	Up to 3 years	No