NCT00401401 - Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

30

Conditions

Head and Neck Cancer Squamous Cell Cancer

Interventions

zalutumumabDRUG

Eight weekly infusions

cisplatinDRUG

Infusions

RadiotherapyPROCEDURE

Daily in the treatment period

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

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

Outcomes

Primary Outcomes

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.

Time frame: Overall Study

Secondary Outcomes

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 frame: Up to 3 years

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

Time frame: Up to 3 years

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

Time frame: Up to 3 years