Stage IV Small Intestinal Adenocarcinoma AJCC v8 Clinical Trial
Official title:
Phase II Study of Bevacizumab Combined With Capecitabine and Oxaliplatin (CAPOX) in Patients With Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater
This phase II trial studies how well bevacizumab given with capecitabine and oxaliplatin work in treating participants with small bowel or ampulla of Vater adenocarcinoma that has spread to other places in the body. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs using in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bevacizumab, capecitabine, and oxaliplatin may work better in treating participants with small intestinal or ampulla of Vater adenocarcinoma.
PRIMARY OBJECTIVES:
I. To determine the progression-free survival (PFS) at six months for patients with advanced
adenocarcinoma of the small bowel (small intestine) or ampulla of Vater treated with
capecitabine, oxaliplatin (CAPOX) and bevacizumab.
SECONDARY OBJECTIVES:
I. To determine the response rate (RR) for CAPOX and bevacizumab. II. To determine the
overall progression free survival for CAPOX and bevacizumab.
III. To determine the overall survival (OS) for CAPOX and bevacizumab. IV. To determine the
toxicity of CAPOX and bevacizumab.
OUTLINE:
Participants receive oxaliplatin via central venous catheter (CVC) over 2 hours and
bevacizumab intravenously (IV) over 30-90 minutes on day 1. Participants also receive
capecitabine orally (PO) twice daily (BID) on days 1-14. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 10 and 30 days, and then
every 3 months thereafter.
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