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