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Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery

NCT00448760 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-02-07

Study results available
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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.

Conditions

  • Esophageal Cancer

Interventions

DRUG

Docetaxel

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

DRUG

Floxuridine

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

DRUG

Leucovorin

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

DRUG

Oxaliplatin

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

GENETIC

Microarray analysis

Analysis of tumor for pathologic response to protocol therapy

GENETIC

reverse transcriptase-polymerase chain reaction

Analysis of tumor for pathologic response to protocol therapy

PROCEDURE

Conventional surgery

Surgical removal of tumor for correlative studies

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Bach Ardalan, MD · University of Miami Sylvester Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00448760 on ClinicalTrials.gov