Phase II trial of Cetuximab in combination with chemotherapy (Carboplatinum and Navelbine) for patients with platinum-resistant head- and neckcancer - CCV-NK

Conditions: Platinum-resistant head and neck cancer
MedDRA version: 12.0Level: LLTClassification code 10067821Term: Head and neck cancer

Registration Number: EUCTR2009-013878-40-DK

Lead Sponsor: Odense University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Histological verified planocellular head and neck cancer, where curative intended lokal treatment is not possible.
2. Measurable or non-measurable disease.
3. Disease progressing during or after first line palliative chemotherapy with cisplatinum or patients recurring after concomittant chemo-radiotherapy with cisplatinum and where treatment is not possible.
4. WHO Performance Status 0-2.
5. Age = 18 years.
6. Neutrophil count (ANC) = 1.5 x 109/l and platelets = 100 x 109/l.
7. Normal liver function with bilirubin < 1.5 x UNL (Upper Normal Limit), no UNL for ALAT with liver metastases.
8. Creatinin clearence = 30 ml/min (calculated with Cockroft-Gault formular).
9. Signed informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Other active malignant disease.
2. Patients who are considered not able to follow the treatment plan or follow-up visits.
3. Other serious disease (eg. severe heart disease, AMI within 1 year, active infection).
4. Any condition or treatment which after the opinion of the investigator may expose the patient for a risk or may influence the purpose of the trial.
5. Pregnant or lactating women.
6. Known hypersensitivity towards one or more of the components of the treatment.
7. Prior treatment with either cetuximab or others inhibitors of EGFR during palliative treatment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to find a new effective second line treatment regimen for patients with locally advanced or metastatic head and neck cancer who progressed during or after first-line treatment with cisplatinum.<br><br>Primary objective(s):<br>Response rate (RR) and progression-free survival (PFS)<br>;Secondary Objective: Survival, Toxicity, correlation between efficacy of treatment and tumor markers (EGF-receptor, grade of differentiation;Primary end point(s): The primary objective of the trial is to find a new effective second line treatment regimen for patients with locally advanced or metastatic head and neck cancer who progressed during or after first-line treatment with cisplatinum.<br><br>Primary objective(s):<br>Response rate (RR) and progression-free survival (PFS)<br><br>Secondary objectives:<br>Toxicity<br>Median survival<br>Correlation between efficacy of treatment and tumor markers

Secondary Outcome Measures