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S0408: Capecitabine, Oxaliplatin, and Bevacizumab in Pts Undergoing Surgery for Liver Mets From Colorectal Cancer

NCT00118105 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-01-03

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab before and after surgery may be an effective treatment for liver metastases.

PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with bevacizumab works in treating patients who are undergoing surgery for liver metastases due to colorectal cancer.

Conditions

Interventions

BIOLOGICAL

bevacizumab

Preoperative: 7.5 mg/kg, IV, Day 1 of cycles 1,2,3 Postoperative: 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4

DRUG

capecitabine

Pre \& Post Operative: 1,700 mg/m\^2/day, PO at 12 hr interval, Days 1-14 of cycles 1,2,3,4

DRUG

oxaliplatin

130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4

PROCEDURE

conventional surgery

Resection

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Jean-Nicolas Vauthey, MD · M.D. Anderson Cancer Center

  • Robert de W. Marsh, MD · University of Florida

  • Cathy Eng, MD · M.D. Anderson Cancer Center

  • Henry Q. Xiong, MD, PhD · M.D. Anderson Cancer Center

  • Kevin G. Billingsley, MD · OHSU Knight Cancer Institute

  • Steven A. Curley, MD · 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
2006-11-30
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00118105 on ClinicalTrials.gov