Cetuximab in Combination With Chemotherapy for Patients With Head and Neck Cancer

Study Overview
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Brief Summary
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This is an open, multicenter phase II study. The purpose is to demonstrate the efficacy of cetuximab in combination with carboplatin and vinorelbine as second line treatment in patients with recurrent or metastatic head and neck cancer who have progressed during or after treatment with first line cisplatinum.

Official Title
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Phase II Trial of Cetuximab in Combination With Chemotherapy (Carboplatin and Navelbine) for Patients With Platinum-resistant Head and Neck Cancer

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Drug: Cetuximab
* Drug: Carboplatin
* Drug: Vinorelbine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically verified squamous cell carcinoma of the head and neck where curatively intended local treatment is not possible. Measurable or non-measurable disease. Disease progression during or after first line palliative chemotherapy with cisplatinum or patients with recurrence < 6 months after primary concomitant chemo-radiotherapy with cisplatinum. WHO Performance Status 0-2. Age ≥ 18 years. Neutrophil count (ANC) ≥ 1.5 x 10^9/l and platelets ≥ 100 x 10^9/l. Normal liver function with bilirubin < 1.5 x UNL (Upper Normal Limit), no UNL for ALAT with liver metastases. Creatinin clearance ≥ 50 ml/min. Signed informed consent. Exclusion Criteria: Other active malignant disease. Patients who are considered unable to follow the treatment plan or follow-up visits. Other serious disease (e.g. severe heart disease, myocardial infarction (MI) within 1 year, active infection). Any condition or treatment which after the opinion of the investigator may expose the patient to a risk or may influence the purpose of the trial. Pregnant or lactating women. Known hypersensitivity towards one or more of the components of the treatment. Prior treatment with either cetuximab or other inhibitors of EGFR.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy<br>Patients will be treated with Cetuximab, Carboplatin and Vinorelbine i.v. day 1, every 2nd week. Patients will be treated until progression and/or in case of unacceptable toxicity or if the patient wishes to stop treatment. | Drug: Cetuximab<br>* Cetuximab 500 mg/m² i.v. day 1, every 2nd week<br>* Other names: Erbitux;Drug: Carboplatin<br>* Carboplatin AUC = 3 i.v. day 1, every 21nd week<br>Drug: Vinorelbine<br>* Vinorelbine 25 mg/m² i.v. day 1, every 2nd week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 2.5 years | 
| Response rate |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | 2.5 years | 
| Median survival |  | 3 years | 
| Correlation between response and evolvement in tumor biology markers. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platinum-resistent head and neck cancer, Cetuximab, Carboplatin, Navelbine, Phase II trial, Combination chemotherapy