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S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer

NCT00109850 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2015-11-18

Study results available
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Summary

RATIONALE: 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. Cetuximab may also stop the growth of esophageal cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy and radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.

Conditions

  • Esophageal Cancer

Interventions

BIOLOGICAL

cetuximab

400mg/m\^2 loading dose, intravenous (IV) over 120 min, day 1 of cycle 1 only. 250mg/m\^2 maintenance dose, IV over 60 min, Days 8 \& 15 of Cycle 1 and Days 1, 8, and 15 of subsequent cycles.

DRUG

cisplatin

30mg/m\^2, bolus intravenous (IV), on Days 1 \& 8 of each cycle.

DRUG

irinotecan hydrochloride

65mg/m\^2, intravenous (IV) over 30 min, on Days 1 \& 8 of each cycle.

RADIATION

radiation therapy

The total dose to the prescription point will be 5,040 cGy given in 28 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter. The dose variation in the planning target volume (PTV) will be +7% and -5% of the prescription point dose.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Charles R. Thomas, MD · OHSU Knight Cancer Institute

  • Charles D. Blanke, MD, FACP · OHSU Knight Cancer Institute

  • James L. Abbruzzese, MD · M.D. Anderson Cancer Center

  • Lisa Hammond, MD · The University of Texas Health Science Center at San Antonio

  • Vivek Mehta, MD · Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2009-09-30
Completion
2012-05-31

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 NCT00109850 on ClinicalTrials.gov