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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01208103
Phase
PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Capecitabine — DRUG
    Given PO
  • Oxaliplatin — DRUG
    Given CVC

Study Details

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.

Key Dates

First listed
Sep 23, 2010
Start date
May 6, 2011
Status verified
Sep 2020
Primary completion
Mar 7, 2018
Completion
Mar 7, 2018

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (oxaliplatin, bevacizumab, capecitabine)
    Participants receive oxaliplatin via CVC over 2 hours and bevacizumab IV over 30-90 minutes on day 1. Participants also receive capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With Progression-free Survival (PFS) at Six Months [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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