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.
- Conditions
- Metastatic or recurrent Head and Neck Squamous Cell Carcinoma
- Registration Number
- EUCTR2008-007097-38-FR
- Lead Sponsor
- Boehringer-Ingelheim France
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 146
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
Progressive disease within 3 months after completion of curative intent treatment for localized/locoregionally advanced disease.
Prior use of an EGFR or erbB2 inhibitor in the recurrent/metastatic disease setting
More than 2 chemotherapeutic regimens given for recurrent/metastatic disease.
Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
Use of alcohol or drugs incompatible with patient participation in the study in the investigator's opinion.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;Secondary Objective: Tumor shrinkage after cross-over (stage 2) of the trial. <br>Best RECIST assessment<br>Progression-free survival<br>Overall survival<br>Quality of life<br>Occurrence and intensity of adverse events<br>Change from baseline for all laboratory tests<br>Analysis of Pharmacokinetics<br>Analysis of Biomarkers;Primary end point(s): Tumor shrinkage before cross-over (stage 1) of the trial
- Secondary Outcome Measures
Name Time Method