Comparing 2 doses of Trastuzumab in HER2+ Metastatic Gastric Cancer

• Research type

  Research Study

• Full title

  A randomized, open-label, multicenter Phase IIIb study comparing two trastuzumab dosing regimens, each in combination with cisplatin/capecitabine chemotherapy, as first-line therapy in patients with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

• IRAS ID

  87310

• Contact name

  David Ferry

• Sponsor organisation

  F Hoffman-La Roche

• Eudract number

  2011-001526-19

• ISRCTN Number

  N/A

• Research summary

  Cancer of the stomach is the 13th most common cancer amongst adults in the UK. Although the number of patients being diagnosed with stomach cancer in general is falling, the number of patients being diagnosed with cancer which forms in the region between the stomach and the oesophagus is increasing. Herceptin© (a man-made antibody) has been approved in combination with chemotherapy (cisplatin and capecitabine or flurouracil), for the treatment of patients with HER2-overexpressing (the tumour has a high amount of protein called HER2 on the surface of the cancer cells which Herceptin© targets, helping it to die and making it more visible to your immune system) stomach cancer or cancer of the region between the stomach and the oesophagus who have not received prior treatment for spreading disease. There are some patients who do not respond as well as others with HER2 over expressing stomach cancer when treated with Herceptin and this study aims to find out if giving patients a higher dose of Herceptin than the current approved dose, will improve their response. Patients for this study would not have had any previous treatment for their stomach cancer and will need to be checked if they are HER2 positive. They will either be treated with the current dose or higher dose of Herceptin© plus chemotherapy for up to 6 cycles and continue on the dose of Herceptin© until their disease starts to grow. This is an international study with up to 4 centres planned in the UK.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  12/NE/0016

• Date of REC Opinion

  13 Feb 2012

• REC opinion

  Further Information Favourable Opinion