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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Cetuximab, Paclitaxel, Carboplatin, and Radiotherapy in Patients With Unresectable Stage IIIA or IIIB Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	RTOG-0324 NCT00081302

Trial Description

Purpose:

Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in 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. Giving cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells.

This phase II trial is studying how well giving cetuximab together with paclitaxel, carboplatin, and radiation therapy works in treating patients with unresectable stage IIIA or stage IIIB non-small cell lung cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• No brain metastases
• No previous chemotherapy
• No previous radiation therapy to the chest or neck
• No previous surgery to remove this cancer
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive a 2-hour infusion of cetuximab on day 1. Beginning in week 2, they will receive a 1-hour infusion of cetuximab, a 1-hour infusion of paclitaxel, and an infusion of carboplatin once a week for 7 weeks. They will also undergo radiation therapy 4-5 days a week in weeks 2-8. Patients will then receive a 1-hour infusion of cetuximab once a week in weeks 9-17, plus a 3-hour infusion of paclitaxel and an infusion of carboplatin in weeks 12 and 15.

Patients will be evaluated at 1 month, every 3 months for 2 years, every 4 months for 2 years, and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

George Blumenschein, MD, Protocol chair		Ph: 713-792-6363; 800-392-1611

Registry Information
Official Title		A Phase II Study Of Cetuximab (C225) In Combination With Chemoradiation In Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
Trial Start Date		2004-03-08
Registered in ClinicalTrials.gov		NCT00081302
Date Submitted to PDQ		2004-01-06
Information Last Verified		2005-06-10
NCI Grant/Contract Number		U10-CA21661

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