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Be Part of Research - Trial Details - A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer
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A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer

Stopped

Open to: ALL

Age: 18.0 - N/A

Southampton Wolverhampton Leicester Denbighshire

Medical Conditions

Stomach Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This randomized, open-label, multicenter, international Phase IIIb study will compare the efficacy and safety of two Herceptin dosing regimens in combination with cisplatin/capecitabine chemotherapy in participants with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma. Participants who have not received prior treatment for metastatic disease will be randomized to receive Herceptin intravenously as either an 8-milligram per kilogram (mg/kg) loading dose followed by 6 mg/kg every 3 weeks (q3w) as standard of care or an 8-mg/kg loading dose followed by 10 mg/kg q3w until disease progression. Capecitabine will be administered for 6 cycles at a dose of 800 milligrams per meter-squared (mg/m\^2) orally twice a day on Days 1 to 14 of each 3-week cycle, and cisplatin will be administered intravenously for 6 cycles at a dose of 80 mg/m\^2 on Day 1 of each 3-week cycle. Herceptin will be continued until disease progression occurs.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2011 Feb 2015

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Capecitabine will be administered at a dose of 800 mg/m\^2 orally twice daily for 14 days q3w for up to 6 cycles (Cycles 1 to 6).

Intervention Arm Group : Capecitabine + Cisplatin + Herceptin (10 mg/kg);Capecitabine + Cisplatin + Herceptin (6 mg/kg);

Intervention Type : DRUG
Intervention Description : Cisplatin will be administered at a dose of 80 mg/m\^2 intravenously q3w on Day 1 of each 3-week cycle for up to 6 cycles (Cycles 1 to 6).

Intervention Arm Group : Capecitabine + Cisplatin + Herceptin (10 mg/kg);Capecitabine + Cisplatin + Herceptin (6 mg/kg);

Intervention Type : DRUG
Intervention Description : Herceptin will be administered at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 or 10 mg/kg (depending upon treatment assignment) q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.

Intervention Arm Group : Capecitabine + Cisplatin + Herceptin (10 mg/kg);Capecitabine + Cisplatin + Herceptin (6 mg/kg);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Southampton
    SO16 6YD
  • Wolverhampton
    WV10 0QP
  • Leicester
    LE1 5WW
  • Denbighshire
    LL185UJ


The study is sponsored by Hoffmann-La Roche



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Read full details for Trial ID: NCT01450696
Last updated 05 October 2016

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