Platinum-resistant head and neck cancer MedDRA version: 12.0 Level: LLT Classification code 10067821 Term: Head and neck cancer
Conditions
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Primary objective(s): Response rate (RR) and progression-free survival (PFS) ;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. Primary objective(s): Response rate (RR) and progression-free survival (PFS) Secondary objectives: Toxicity Median survival Correlation between efficacy of treatment and tumor markers | — |
Countries
Denmark
Outcome results
None listed