Docetaxel versus Docetaxel and Lapatinib in recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). An open label multicenter randomized phase II study.A study of the Dutch Head and Neck Cancer Group (DHNCG)(NWHHT 08-02).
Recruiting
- Conditions
- patients with recurrent SCCHN not amendable for local therapy or patients with metastatic SCCHNKeywords: SCCHN, recurrent and/or metastatic disease, docetaxel, lapatinib
- Registration Number
- NL-OMON22962
- Lead Sponsor
- The Netherlands Cancer Institute Antoni van Leeuwenhoek hospitalDutch Head and Neck Cancer Group (DHNCG)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 74
Inclusion Criteria
1. ≥18 years of age;
2. Histologically or cytologically confirmed diagnosis of SCCHN;
Exclusion Criteria
1. Patients previously treated with EGFR inhibitor;
2. Patients previously treated with Docetaxel or Paclitaxel;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of this study is to select the candidate treatment with the highest level of activity for subsequent phase III testing (selection design). Activity is defined as clinical benefit (CR, PR or stable disease) in patients with recurrent SCCHN not amendable for local therapy or metastatic SCCHN. Clinical benefit will be assessed in week 8, i.e. after two courses of docetaxel.
- Secondary Outcome Measures
Name Time Method 1. To evaluate the two treatment groups with respect to the following: Progression free survival (PFS), overall survival (OS) and efficacy (defined as CR + PR);<br /><br>2. To determine the qualitative and quantitative toxicities associated with docetaxel and lapatinib or docetaxel only in subjects with local or locoregional recurrence not amendable for local therapy or metastatic disease;<br /><br>3. To evaluate volumetric tumour responses and to correlate those with tumour responses based on RECIST criteria;<br /><br>4. To evaluate and compare quality of live in the two treatment groups using Quality of life questionnaire (QLQ)-C30 (Version 3.0) and the head and neck cancer-specific QLQ-H&N35.