CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Capecitabine, Oxaliplatin, Cetuximabdrug
Likely dose
Capecitabine, Oxaliplatin, Cetuximab 1,000 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/NCT00398398
NCT00398398Phase 2Completed
CompareCT.gov

A Prospective Phase II Study of Cetuximab (Erbitux®) in Combination With XELOX [XELoda® (Capecitabine) and OXaliplatin] in Patients With Advanced Gastric Cancer

Asan Medical Center·interventional·Posted Nov 10, 2006·Updated Jan 7, 2020

In Brief

A Phase 2 clinical trial evaluating Capecitabine, Oxaliplatin, Cetuximab for Gastric Cancer. Completed, enrolled 44 participants across 3 sites.

Detailed Summary

The combination of capecitabine and oxaliplatin as 'backbone' regimen, adding a newer biologic agent, cetuximab, is a reasonable strategy of further chemotherapy development in advanced gastric cancer, which is the investigators study rationale.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer
CountriesSouth Korea
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 10, 2006
Enrollment StartNov 1, 2006
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.6 years ago

Interventions

Capecitabine, Oxaliplatin, Cetuximabdrug

Xelox(Capecitbine, Oxaliplatin) and Cetuximab every three week; Capecitabine 1,000 mg/m2 was administered twice daily on days 1-14. Oxaliplatin 130 mg/m2 i.v. for 2 h was given on day 1 after cetuximab infusion. Cetuximab at an initial loading dose of 400 mg/m2 i.v. for 2 h and, thereafter, maintenance dose of 250 mg/m2 for 1 h every week.