patients with recurrent SCCHN not amendable for local therapy or patients with metastatic SCCHN Keywords: SCCHN, recurrent and/or metastatic disease, docetaxel, lapatinib
Conditions
Interventions
Patients will be randomised between two study arms, i.e:
1. 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
2. Arm B: Docetaxel at a dose of 75 mg/m² as 1 hour i.v. infusion on day 1 every 3 weeks and Lapatinib 1250 mg o.d. day 1 and every day thereafter continuously until disease progression.
Prophylacti
Sponsors
The Netherlands Cancer Institute Antoni van Leeuwenhoek hospital
Dutch Head and Neck Cancer Group (DHNCG)
Eligibility
Inclusion criteria
Inclusion criteria: 1. ≥18 years of age; 2. Histologically or cytologically confirmed diagnosis of SCCHN; 3. Local or locoregional recurrence not amendable for local therapy or metastatic disease; 4. Tumor tissue available for immunohistochemical evaluation of EGFR 1 and 2 expression; 5. WHO performance 0-2; 6. Measurable or evaluable disease (RECIST); 7. Effective contraception for both male and female subjects if risk of conception exists; 8. Neutrophils ≥1.5 x 109 cells/L, platelet count ≥ 100 x 109 cells/L and hemoglobin ≥ 6 mmol/L; 9. Total bilirubin within normal institutional limits (ULN); 10. Aspartate-aminotransferase (AST) and alanine-aminotransferase (ALT) ≤2,5 × ULN; 11. Creatinine clearance > 60 mL/min; 12. Cardiac ejection fraction ≥ 50% as measured by echocardiogram or MUGA scan; 13. Signed written informed consent before any study related activities are carried out; 14. Expected adequacy of follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients previously treated with EGFR inhibitor; 2. Patients previously treated with Docetaxel or Paclitaxel; 3. Nasopharyngeal carcinoma; 4. Active infection (infection requiring IV antibiotics), including active tuberculosis, and known and declared HIV; 5. Pregnancy (absence confirmed by serum or urine β-HCG test) or lactation period; 6. Concurrent treatment with any other anti-cancer therapy; 7. 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; 8. Current active hepatic or biliary disease (with exception of Gilbert’s syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment); 9. Renal function as measured by creatinine clearance <30 ml/min; 10. 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.); 11. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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); 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; 3. To evaluate volumetric tumour responses and to correlate those with tumour responses based on RECIST criteria; 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. | — |
Contacts
Public ContactJan Paul Boer, de
Plesmanlaan 121
Outcome results
None listed