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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced or Metastatic Cancer of the Esophagus

NCT00002984 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2012-05-24

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than on drug and combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients with advanced or metastatic cancer of the esophagus.

Conditions

  • Esophageal Cancer

Interventions

DRUG

cisplatin

Cisplatin will be given at a dose of 100 mg/m2 at a concentration of 1 mg/ml over one hour on Day 1 and 29 for a total of 2 courses

DRUG

fluorouracil

5-FU will be given at 500 mg/m2 in 1 liter D5 1/2 by continuous infusion every 12 hours for a total of 8 doses (Total 1.0 g/m2/day X 4 days) on Days 1-4 and 29-32 for a total of 2 courses

DRUG

paclitaxel

30 mg/m2 - 45 mg/m2 given weekly. The dose each subject receives will depend on when they enter the study

PROCEDURE

surgical procedure

Surgical resection should take place approximately 4 weeks following completion of the chemotherapy.

RADIATION

radiation therapy

The dose of radiation to the tumor and nodal area will be 4500 cGy given as 180 cGy fractions daily, Monday through Friday, for 5 weeks

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Stephen A. Bernard, MD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-03-31
Primary Completion
2006-05-31
Completion
2007-01-31

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 NCT00002984 on ClinicalTrials.gov