NCT01208103

Bevacizumab, Capecitabine, and Oxaliplatin in Treating Advanced Small Intestinal or Ampulla of Vater Adenocarcinoma

Phase II Study of Bevacizumab Combined With Capecitabine and Oxaliplatin (CAPOX) in Patients With Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ampulla of Vater Adenocarcinoma
• Small Intestinal Adenocarcinoma
• Stage III Ampulla of Vater Cancer AJCC v8
• Stage III Small Intestinal Adenocarcinoma AJCC v8
• Stage IIIA Ampulla of Vater Cancer AJCC v8
• Stage IIIA Small Intestinal Adenocarcinoma AJCC v8
• Stage IIIB Ampulla of Vater Cancer AJCC v8
• Stage IIIB Small Intestinal Adenocarcinoma AJCC v8
• Stage IV Ampulla of Vater Cancer AJCC v8
• Stage IV Small Intestinal Adenocarcinoma AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Given IV
DRUG	Capecitabine	Given PO
DRUG	Oxaliplatin	Given CVC

Timeline

• Start date: 2011-05-06
• Primary completion: 2018-03-07
• Completion: 2018-03-07
• First posted: 2010-09-23
• Last updated: 2020-09-03
• Results posted: 2020-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study