CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 245 enrolled
Drug / intervention
cetuximab +3 morebiological
Likely dose
Not stated in 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/NCT00381706
NCT00381706Phase 2Completed

Randomized Phase II Study of ECF-C, IC-C, or FOLFOX-C in Metastatic Esophageal and GE Junction Cancer

Alliance for Clinical Trials in Oncology·interventional·Posted Sep 28, 2006·Updated Sep 29, 2021

In Brief

A Phase 2 clinical trial evaluating cetuximab, ECF, and 2 other interventions for Esophageal Cancer. Completed, enrolled 245 participants across 227 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy 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 more than one chemotherapy drug (combination chemotherapy) together with cetuximab may kill more tumor cells. PURPOSE: This randomized phase II trial is studying three different combination chemotherapy regimens to compare how well they work when given together with cetuximab in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 28, 2006
Enrollment StartSep 15, 2006
Primary CompletionApr 1, 2011
Study CompletionOct 15, 2014
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 19.8 years ago

Interventions

cetuximabbiological

given IV

ECFdrug

epirubicin and 5-fluorouracil given IV

ICdrug

cisplatin and irinotecan given IV

FOLFOXdrug

oxaliplatin , leucovorin and 5-fluorouracil IV