Ancillary Study for subjects randomised for protocol EMR 200048-052

• Research type

  Research Study

• Full title

  EXPAND (Erbitux in combination with Xeloda and cisplatin in advanced esophago-gastric cancer)Ancillary Study: Analysis of genetic variations from subjects randomized in main study protocol EMR 200048-052

• IRAS ID

  8513

• Sponsor organisation

  Merck KGaA, Darmstadt, Germany

• Eudract number

  2007-004219-75

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  <table cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-right: 9pt; padding-left: 9pt; padding-bottom: 0cm; padding-top: 0cm"> This ancillary study is linked to the main study. There will be a collection of a 5 ml blood sample for the analysis of genetic variations to identify potential correlations with response to treatment. The ancillary study is designed to evaluate the correlation between normal genetic variations and response to treatment (capecitabine and cisplatin alone or in combination with cetuximab, in advanced gastric adenocarcinoma patients enrolled in the cetuximab phase III trial EMR 200048-052. A 5ml blood sample will be taken so as to extract DNA. Genetic variation analysis will consist of a targeted approach focused on the FCGR gene family coupled to a genome wide analysis. The EXPAND (Main) study will enrol approximately 870 participants in around 25 countries worldwide suffering from advanced gastric cancer (cancer of the stomach which cannot be removed by surgery). The standard treatment for this disease consists of combination chemotherapy. The aim of the EXPAND study is to find out, if the treatment of patients with advanced gastric cancer can be improved by adding a therapeutic antibody, called cetuximab or Erbitux© (a protein that reacts with a specific site, on the surface of the cancer cells) to a standard combination chemotherapy of cisplatin and capecitabine (Xeloda©). Cetuximab has been shown to improve the outcome of patients with advanced colorectal cancer, head and neck cancer and advanced lung cancer when combined with chemotherapy. After evaluation of eligibility for study participation patients will be assigned randomly (like flipping a coin) to one of two treatment groups: standard chemotherapy (cisplatin and capecitabine) with or without cetuximab. There are equal chances to be assigned to each of the two groups. Cisplatin is applied by infusion every three weeks, capecitabine tablets are taken orally twice daily. In the treatment group receiving cetuximab, cetuximab is given by an infusion every week. Assessments will include imaging of the tumour (abdomen and chest) by CT scan or MRI. Scans will be performed at the beginning of study participation and then every 6 weeks after the start of treatment. The assessments will also include blood tests,ECG, physical examination and a quality of life questionnaire. Patients will continue the study treatment as long as they are benefiting from the treatment (no progression of the tumour and no unacceptable side effects). A final study visit will be performed at least 6 weeks after the last administration of study treatment. </td> </tr> </tbody></table>

• REC name

  Wales REC 3

• REC reference

  08/MRE09/71

• Date of REC Opinion

  17 Feb 2009

• REC opinion

  Further Information Favourable Opinion