LEO (Lapatinib in Early Oesophago-gastric Cancer)

• Research type

  Research Study

• Full title

  A study of lapatinib in combination with oxaliplatin and capecitabine in early HER-2 overexpressing oesophageal and gastric cancers

• IRAS ID

  32088

• Contact name

  Hugo Ford

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust

• Eudract number

  2010-019602-16

• Research summary

  Cancer of the oesophagus and stomach is a disease with a poor prognosis. Even after successful "curative" surgery, 5 year survival rates are generally less than 40%. Standard treatment for both cancers at present is preoperative chemotherapy with a combination of the drugflurouracil and a platinum agent such as cisplatin or oxaliplatin. There is a pressing need to develop new treatments for this disease.Lapatinib is an oral drug which specifically targets the HER-2 protein, which is known to be overexpressed in some cancers. Lapatinib has been shown to be clinically effective in a number of cancers including breast cancer. HER-2 protein is overexpressed in approximately 20% of cancers of the oesophagus and stomach. In these patients trastuzumab (Herceptin) has been shown to add to the effect of chemotherapy in patients with advanced disease in a phase III randomised trial. It is possible to detect the effect of lapatinib on cells in the laboratory. Furthermore studies with Positron Emission Tomography (PET) scanning in patients with early oesophageal cancer have shown that patients in whom PET activity is reduced by chemotherapy, are more likely to respond to treatment and have better outcomes. In this trial we are planning to administer lapatinib for 10 days to patients with HER-2 expressing early oesophageal and gastric cancers. We will then assess from a tissue biopsy and a PET scan whether or not there is any biological evidence of response. Patients will then be treated with lapatinib in combination with a standard chemotherapy regimen. Outcomes will be assessed by standard response criteria as well as by analysing tissue removed at surgery for molecular and clinico-pathological evidence of response.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  10/H0106/73

• Date of REC Opinion

  3 Nov 2010

• REC opinion

  Favourable Opinion