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Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer

NCT00483405 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-07-12

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, 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 cetuximab, 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. Giving chemotherapy together with a monoclonal antibody may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with cetuximab works in treating patients with advanced liver cancer.

Conditions

Interventions

BIOLOGICAL

cetuximab

250 mg/m2, intravenously, once per week

DRUG

capecitabine

850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.

DRUG

oxaliplatin

130 mg/m2, intravenously on Day 1 of each 21 day cycle

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Bert H. O'Neil, MD · UNC Lineberger Comprehensive Cancer Center

  • Michael A. Morse, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-02-28
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00483405 on ClinicalTrials.gov