CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
cetuximab +2 morebiological
Likely dose
cetuximab 250 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00483405
NCT00483405Phase 2Completed

Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Jun 7, 2007·Updated Jul 12, 2017

In Brief

A Phase 2 clinical trial evaluating cetuximab, capecitabine, and 1 other intervention for Liver Cancer. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 7, 2007
Enrollment StartOct 1, 2006
Primary CompletionFeb 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.1 years ago

Interventions

cetuximabbiological

250 mg/m2, intravenously, once per week

capecitabinedrug

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.

oxaliplatindrug

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