SCCHN
Conditions
Interventions
Arm A:
Docetaxel at a dose of 75 mg/m² as 1 hour i.v. infusion on day 1 every 3
weeks until disease progression
Arm B:
Docetaxel at a dose of 75 mg/m² as 1 hour i.v. infusion on day 1 every 3 weeks
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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) 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to select the candidate treatment with the highest level of activity for subsequent phase III testing. 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
| Measure | Time frame |
|---|---|
| To evaluate the two treatment groups with respect to the following: progression free survival (PFS), overall survival (OS), efficacy (defined as CR + PR) and quality of life. | — |
Countries
Netherlands
Outcome results
None listed