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

NCT01208103 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-09-03

Study results available
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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.

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

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Capecitabine

Given PO

DRUG

Oxaliplatin

Given CVC

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Michael Overman · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-06
Primary Completion
2018-03-07
Completion
2018-03-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01208103 on ClinicalTrials.gov