Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Dr Paula Kareclas


Contact details

Addenbrookes Hospital
Oncology Clinical Trials S4
Box 279
Hills Road
United Kingdom

Additional identifiers

EudraCT number

2010-019602-16 number

Protocol/serial number


Study information

Scientific title

A study of Lapatinib in combination with oxaliplatin and capecitabine in Early HER-2 overexpressing Oesophageal and gastric cancers



Study hypothesis

This study will test whether the ex vivo molecular response on a pre-treatment biopsy can predict the molecular response on a biopsy taken after 10 days of treatment with lapatinib. The study will also report observations of patterns of radiological, functional imaging and pathological response associated with molecular response

Ethics approval

South West 3 REC, 26/10/2010, 10/H0106/73

Study design

Non-randomised, interventional, observational qualitative trial

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

No participant information sheet available


Upper Gastro-Intestinal Cancer; Oesophagus, Stomach


1. All 25 patients will be treated with lapatinib, there is no control arm
2. Fresh biopsies will be taken prior to lapatinib treatment start and 10 days post treatment start
3. All patients will have blood tests and renal function assessment prior to study entry and then after 31, 52 and 72 days of treatment
4. Treatment with lapatinib, oxaliplatin and capecitabine
5. All patients have a CT scan of thorax and abdomen prior to therapy and then another one after 3 cycles of chemotherapy for tumour assessmnet
6. All patient undergo a baseline whole body FDG-PET/CT examination at study entry and then 10 days after start of lapatinib therapy
7. Follow up length: 24 month(s)
8. Study entry : registration only

Intervention type



Phase IV

Drug names

Primary outcome measure

1. Molecular response
2. Timepoint(s): 10 days post treatment with lapatinib

Secondary outcome measures

1. FDG PET response timepoint(s): 10 days post treatment with lapatinib
2. Objective radiological response timepoint(s): 72 days post treatment
3. Pathological complete response timepoint(s): 102 days post treatment

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Histologically confirmed gastric or oesophageal adenocarcinoma
2. Human Epidermal growth factor Receptor 2 (HER-2) 3+ on IHC OR HER-2 2+ on IHC but shown to have HER-2 amplification by (Fluorescent In-Situ Hybridization) FISH
3. Decision to treat with curative intent
4. Deemed to require chemotherapy prior to surgery using standard management algorithms
5. Ability to swallow oral medication
6. Baseline 18FDG PET/CT scan showing no evidence of distant metastases
7. Adequate haematological parameters: ANC = 1.0 x 109/L; WBC = 3.0 x 109/L; Plt = 100 x 109/L; haemoglobin (Hb) = 9g/dL (can be post-transfusion)
8. Adequate renal function (Measured or calculated creatinine clearance = 60 ml/min- if calculated the Cockcroft-Gault equation (Appendix A) to be used
9. Adequate liver function: serum Bilirubin = 1.5 x ULN; ALT/AST = 1.5 x ULN; ALP = 2.5 x ULN
10. Age >18 years
11. Women of child bearing potential using medically approved contraception (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential)
12. Male patients using barrier contraceptives during the trial and for 6 months after the completion of the trial
13. Target gender: male & female
14. Lower age limit 18 years

Participant type


Age group




Target number of participants

UK Sample Size: 25

Participant exclusion criteria

1. Advanced disease not amenable to surgery
2. Previous diagnosis of malignancy (excluding adequately treated Cervical carcinoma in situ or Basal cell carcinoma of the skin)
3. Abnormal Cardiac function (LVEF below normal as measured by echocardiogram or MUGA scan)
4. History of clinically significant cardiac disease e.g. symptomatic coronary artery disease, uncontrolled cardiac dysrhythmia or myocardial infarction within the last 12 months)
5. History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan
6. Known peripheral neuropathy >Grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible)
7. Inability to give informed consent
8. Hypersensitivity to lapatinib or oxaliplatin or capecitabine
9. Prior treatment with chemotherapy or lapatinib or other specific anticancer therapy
10. Squamous cell carcinomas, unclear differentiation type, sarcomas, carcinoid or GIST
11. Known positive tests for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection
12. Pregnancy/breastfeeding
13. 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)
14. Treatment with another investigational agent within 30 days of commencing study treatment
15. Known or suspected dihydropyrimidine dehydrogenase deficiency (DPD)
16. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
United Kingdom

Trial participating centre

University College London Hospital
235 Euston Road
United Kingdom

Sponsor information


Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Addenbrookes Hospital
Hills Road
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name


Alternative name(s)

GlaxoSmithKline plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype



United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

IPD sharing statement
The protocol has not specified these data sharing requirements, and patients have not consented to data sharing (recruited from 2011–2013) therefore this is not applicable. The trial is currently in the process of being archived.

Intention to publish date

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2015 results in

Publication citations

Additional files

Editorial Notes

04/05/2018: The following changes were made: 1. South West 3 REC was added as the ethics committee. 2. The overall trial start date was changed from 01/04/2011 to 31/03/2010. 3. The overall trial end date was changed from 16/11/2013 to 31/07/2015. 4. An IPD sharing statement has been added. 04/05/2018: Publication reference added. 19/01/2018: No publications found in PubMed, verifying study status with principal investigator.