CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
FOLFOX +2 moredrug
Likely dose
FOLFOX 85 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/NCT00591123
NCT00591123Phase 2Completed
CompareCT.gov

A Phase II Study of Erlotinib and Modified FOLFOX-6 (5-Fluorouracil, Leucovorin and Oxaliplatin) in Previously Untreated Patients With Unresectable or Metastatic Adenocarcinoma of the Esophagus and Gastric Cardia

Translational Oncology Research International·interventional·Posted Jan 11, 2008·Updated Oct 1, 2021

In Brief

A Phase 2 clinical trial evaluating FOLFOX, 5-FU, and 1 other intervention for Unresectable Adenocarcinoma of the Esophagus and 3 related conditions. Completed, enrolled 38 participants across 2 sites.

Detailed Summary

In this study, Erlotinib and 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (a regimen known also as FOLFOX-6) will be the chemotherapy study drugs. The main purpose of this study is to test the safety and effectiveness of this combination of chemotherapy drugs and to see how they affect your cancer. Another purpose of this study is to examine samples from your blood and tumor. This research will be done to better understand how subjects respond to treatment. Specifically, researchers will look at the way your genes and proteins respond to drugs like those used in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUnresectable Adenocarcinoma of the Esophagus, Metastatic Adenocarcinoma of the Esophagus, Unresectable Adenocarcinoma of Gastric Cardia, Metastatic Adenocarcinoma of Gastric Cardia
CountriesUnited States
CollaboratorsUniversity of California, Los Angeles, Sanofi, OSI Pharmaceuticals

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2008
Enrollment StartDec 1, 2007
Primary CompletionJun 1, 2011
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 18.5 years ago

Interventions

FOLFOXdrug

Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions

5-FUdrug

5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home.

Erlotinibdrug

All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.