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)

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 74

Inclusion Criteria

•>=18 years of age
•Histologically or cytologically confirmed diagnosis of SCCHN
•Local or locoregional recurrence not amendable for local therapy or metastatic disease
•Tumor tissue available for immunohistochemical evaluation of EGFR 1 and 2 expression
•Measurable or evaluable disease (RECIST)
•WHO performance 0-2
•Effective contraception for both male and female subjects if risk of conception exists
•Neutrophils >=1.5 x 109 cells/L, platelet count >= 100 x 109 cells/L and hemoglobin >= 6 mmol/L
•Total bilirubin within normal institutional limits (ULN)
•Aspartate-aminotransferase (AST) and alanine-aminotransferase (ALT) <=2.5 × ULN
•Creatinin within normal institutional limits or Creatinine clearance > 60 mL/min
•Cardiac ejection fraction >= 50% as measured by echocardiogram or MUGA scan
•Signed written informed consent before any study related activities are carried out
•Expected adequacy of follow-up

Exclusion Criteria

•Patients previously treated with EGFR inhibitor
•Patients previously treated with Docetaxel or Paclitaxel
•Nasopharyngeal carcinoma
•Active infection (infection requiring IV antibiotics), including active tuberculosis, and known and declared HIV.
•Pregnancy (absence confirmed by serum or urine β-HCG test) or lactation period
•Concurrent treatment with any other anti-cancer therapy.
•Class 3-4 cardiac morbidity, as defined by the new York Heart association Criteria (e.g. uncontrolled or symptomatic congestive heart failure, myocardial infarction within six months prior to the start of study, uncontrolled or symptomatic angina) and any cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
•Current active hepatic or biliary disease (with exception of Gilbert*s syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
•Renal function as measured by creatinine clearance <30 ml/min
•Presence of severe and/or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes mellitus, uncontrolled liver disease, including chronic viral hepatitis judged at risk of reactivation, uncontrolled active infection such as HIV infection, etc.)
•Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation; Chemotherapy or other anti-cancer therapy for the recurrence or metastatic disease; chemotherapy for initial treatment, i.e. chemoradiotherapy, is allowed, unless it has been stopped 3 weeks before inclusion

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to select the candidate treatment with<br /><br>the highest level of activity for subsequent phase III testing. Activity is<br /><br>defined as clinical benefit (CR,PR or stable disease) in patients with<br /><br>recurrent SCCHN not amendable for local therapy or metastatic SCCHN. Clinical<br /><br>benefit will be assessed in week 8, i.e. after two courses of docetaxel.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the two treatment groups with respect to the following: progression<br /><br>free survival (PFS), overall survival (OS), efficacy (defined as CR + PR) and<br /><br>quality of life.</p><br>

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