Patients with advanced squamous cell carcinoma of the head and neck who relapsed after a platinum containing chemotherapy or after a cisplatin-containing chemoradiotherapy are eligible for this study.
Conditions
Interventions
Trade Name: Erbitux
Product Name: Erbitux
Product Code: EMD271786
Pharmaceutical Form: Solution for infusion
Sponsors
Charité Berlin, CBF
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed written informed consent • Male or female > 18 years of age • Histologically confirmed recurrent or metastatic stage III/IV squamous cell carcinoma of the head and neck • Relapse after cisplatin containing chemoradiotherapy or Relapse after platinum containing 1st-line chemotherapy • No intercurrent anticancer treatment since platinum-failure • At least one measurable lesion according to the RECIST criteria (> 10 mm with spiral CT or > 20 mm with conventional CT) must be present • ECOG Performance Status 0-1 • Adequate bone marrow function: leucocytes > 3.0 x 109/L, neutrophils > 1.5 x 109/L, platelets > 80 x 109/L, hemoglobin > 10.0 g/dL • Adequate liver function: Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Prior treatment with docetaxel • Prior exposure to EGFR pathway targeting therapy • Other serious illness or medical conditions: - Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4; - Significant neurologic or psychiatric disorders including dementia or seizures; - Active uncontrolled infection; - Active disseminated intravascular coagulation; - Other serious underlying medical conditions which could impair the ability of the patient to participate in the study; • Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 and/or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass • Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease. • Having participated in another clinical trial or having received any investigational agent in the preceding 30 days • Known allergic/hypersensitivity reaction to any of the components of the treatment • Pregnancy (absence confirmed by serum/urine ?-HCG) or breast-feeding • Other active malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix • Legal incapacity or limited legal capacity • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is the objective response rate (CR + PR) according to the RECIST criteria to cetuximab in combination with docetaxel for the treatment of relapsed head and neck carcinoma: A clinical phase II trial ;Secondary Objective: • Response rate in relation to cisplatin sensitivity • Time to progression • Overall survival • Quality of life (EORTC QLQ C-30) • Safety profile of cetuximab in combination with docetaxel in patients with head and neck cancer ;Primary end point(s): The primary target variable is the objective response rate (CR+PR) according to the RECIST criteria. | — |
Countries
Germany
Outcome results
None listed