A Study of Trastuzumab in Combination With Cisplatin/Capecitabine Chemotherapy in Patients With HER2-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer

Study Status

Open to Enrollment

Study Description

This is a clinical trial for men and women with stomach cancer or cancer of the gastro-esophageal junction (the regison betweeen the stomach and the esophagus, also known as GEJ cancer) who:

  • Have not received anti-cancer medication for their advanced disease
  • Have not had an operation to remove the cancer from the stomach or GEJ region
  • Have HER2-positive cancer (the tumor will be tested at screening to determine this). A high amount of the HER2 protein can cause cancer cells to grow aggressively.

As part of the treatment for this study, participants will receive the drug trastuzumab (also called Herceptin), which is an antibody that blocks HER2. The purpose of this study is to determine how well metastatic stomach or GEJ cancer responds to treatment with different doses of trastuzumab in combination with standard doses of capecitabine and cisplatin.

The FDA has approved a certain dose of trastuzumab in combination with the chemotherapy drugs cisplatin and capecitabine for treatment of people with HER2-positive stomach or GEJ cancer. In this study, we are investigating whether a higher dose of trastuzumab, combined with cisplatin and capecitabine, will increase blood levels of the drug and if that might lead to further improvement in survival time and prolonging the the time until the cancer starts to grow again.

Study participants will be randomly assigned to one of two treatment groups:

  • Group 1: Approved dose of trastuzumab in combination with standard doses of capecitabine and cisplatin. Trastuzumab 8 mg/kg (treatment in Cycle 1 only) followed by 6 mg/kg every 3 weeks until the cancer starts to re-grow or unacceptable side effects occur
  • Group 2: Higher dose of trastuzumab in combination with standard doses of capecitabine and cisplatin. Trastuzumab 8 mg/kg (treatment in Cycle 1 only) followed by a higher doses of trastuzumab of 10 mg/kg (experimental dose) every 3 weeks until the cancer starts to re-grow or unacceptable side effects occur 

Full protocol 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

Disease Status and/or Stage

Metastatic Gastric Cancer

Sponsor

Genentech/Roche

Key Eligibility

  • Men and women age 18 and older
  • Metastatic cancer of the stomach or gastro-esophageal junction (GEJ)
  • HER2-positive tumor
  • No prior chemotherapy for metastatic cancer (prior chemotherapy allowed if it was not given for advanced disease and was given more than 6 months before entering the study>
  • Cancer has not been surgically removed
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Manish Shah, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

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Tel: (646) 962-8232
[email protected]

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