A randomized, open-label Phase II study of BIBW 2992 versus cetuximab (Erbitux®) in patients with metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) after failure of platinum-containing therapy with a cross-over period for progressing patients

INTERVENTION: Product Code: BIBW 2992 Pharmaceutical Form: Film‐coated tablet Current Sponsor code: BIBW 2992 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Product Code: BIBW 2992 Pharmaceutical Form: Film‐coated tablet Current Sponsor code: BIBW 2992 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Trade Name: Erbitux® Product Name: Erbitux® Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cetuximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5‐ Trade Name: Erbitux® Product Name: Erbitux® Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cetuximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5‐ CONDITION: Metastatic or recurrent Head and Neck Squamous Cell Carcinoma PRIMARY OUTCOME: Main Objective: Tumor Shrinkage before cross‐over (Stage 1) of the trial: maximum decrease in the sum of the longest diameters of the target lesions (according to RECIST) compared to baseline, with baseline defined as the sum of tumor measurement of the target lesion longest diameters measured before the patient start the first administration of the randomized treatment. The effect of EGFRvIII mutation on tumor shrinkage will be explored. Primary end point(s): Tumor shrinkage before cross‐over (stage 1) of the trial Secondary Objective: Tumor shrinkage after cross‐over (stage 2) of the trial. ; Best RECIST assessment; Progression‐free survival; Overall survival; Quality of life; Occurrence and intensity of adverse events; Change from baseline for all laboratory tests; Analysis of Pharmacokinetics; Analysis of Biomarkers INCLUSION CRITERIA: Metastatic (stage IV) or recurrent HNSCC Histologically or cytologically confirmed diagnosis of squamous cell carcinomas of the head and the neck. Patients must have documented progressive disease following receipt of prior platinum‐based therapy. Patients must have measurable disease as defined by RECIST criteria. 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