Phase II Trial of CAPOX, Bevacizumab and Trastuzumab for Patients With HER2-Positive Metastatic Esophagogastric Cancer
- We recommend that the participants have a vascular access device, more commonly known
as a PORT, inserted prior to starting chemotherapy. A port is a small device that is
inserted under the skin (usually near the collar bone) by a minor surgical procedure
and is then connected to one of the large veins inside the chest. The port will be
used to give the intravenous medications.
- During the first cycle, the participant will receive trastuzumab intravenously on Day
1. Cycle 2 will then start one week later. On this day, bevacizumab will be given
intravenously first followed by trastuzumab and then oxaliplatin. The participant will
then start taking capecitabine tablets orally twice a day for 14 days. Each treatment
cycle is 21 days long.
- Participants will have the following tests and procedures at specific time points
during study treatment; physical exam, blood tests, CT scan, MUGA scan or
echocardiogram, and urine test.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the major response rate of CAPOX plus bevacizumab plus trastuzumab for patients with HER2-positive metastatic or unresectable esophagogastric adenocarcinoma.
Peter Enzinger, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|