Oesophagogastric adenocarcinoma MedDRA version: 8.1 Level: LLT Classification code 10017758 Term: Gastric cancer MedDRA version: 9.1 Level: LLT Classification code 10001173 Term: Adenocarcinoma of the oesophagus
Conditions
Interventions
Trade Name: Eloxatin
Product Name: Oxaliplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Oxaliplatin
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed gastric or oesophageal adenocarcinoma HER-2 3+ on IHC OR HER-2 2+ on IHC but shown to have HER-2 amplification by FISH Decision to treat with curative intent Deemed to require chemotherapy prior to surgery using standard management algorithms Ability to swallow oral medication Baseline 18FDG PET/CT scan showing no evidence of distant metastases Adequate haematological, renal and hepatic function (Hb = 9.0 g/dL, WBC =3.0 x 109/L, Neutrophils = 1.0 x 109/L, Plt = 100 x 109/L; Measured or calculated creatinine clearance =60 ml/min; ALP = 2.5 x ULN, ALT = 1.5 x ULN and Bilirubin = 1.5 x ULN 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
Exclusion criteria
Exclusion criteria: Advanced disease not amenable to surgery Previous diagnosis of malignancy (excluding adequately treated Cervical carcinoma in situ or Basal cell carcinoma of the skin) Abnormal Cardiac function (LVEF below normal as measured by echocardiogram or MUGA scan) Inability to give informed consent Hypersensitivity to lapatinib Prior treatment with chemotherapy or lapatinib or other specific anticancer therapy Squamous cell carcinomas, unclear differentiation type, sarcomas, carcinoid or GIST Pregnancy/breastfeeding Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is it possible to predict from the pretreatment tumour biopsies whether or not lapatinib will be effective at turning off HER2 signalling?; Secondary Objective: Does the molecular response seen correlate with any of the following: Reduced tumour metabolic activity (as measured by PET scanning) Radiological response by standard criteria Increase in complete (R0) resection rate Rate of pathological complete remission ;Primary end point(s): Molecular response, defined as EITHER: reduction in composite immunohistochemistry score for phosphorylated protein by 2 or more OR: Reduction in ration of phosphorylated total protein by 50% or more on Western Blot | — |
Countries
United Kingdom
Outcome results
None listed