CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Docetaxel +6 moredrug
Likely dose
Docetaxel 25 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/NCT00448760
NCT00448760Phase 2Completed

A Nonrandomized Phase II Study: Feasibility and Outcome of Neo Adjuvant Chemotherapy With Oxaliplatin, Fluorodeoxyuridine (FUdR), Taxotere and Leucovorin in the Treatment of Previously Untreated Advanced Esophago-Gastric Carcinoma

University of Miami·interventional·Posted Mar 19, 2007·Updated Feb 7, 2017

In Brief

A Phase 2 clinical trial evaluating Docetaxel, Floxuridine, and 5 other interventions for Esophageal Cancer. Completed, enrolled 29 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, floxuridine, docetaxel, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with previously untreated stage II or stage III esophageal cancer that can be removed by surgery.

Study Details

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

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 19, 2007
Enrollment StartOct 1, 2004
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 19.3 years ago

Interventions

Docetaxeldrug

Intravenously, 25 mg/m2, over 30 minutes, 2 cycles

Floxuridinedrug

Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles

Leucovorindrug

Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles

Oxaliplatindrug

Intravenously, 85 mg/m2, over 2 hours, 2 cycles

Microarray analysisgenetic

Analysis of tumor for pathologic response to protocol therapy

reverse transcriptase-polymerase chain reactiongenetic

Analysis of tumor for pathologic response to protocol therapy

Conventional surgeryprocedure

Surgical removal of tumor for correlative studies