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

Alternate Title

Phase I Study of Erlotinib and Radiotherapy Plus Either Cisplatin, Etoposide, and Docetaxel or Carboplatin and Paclitaxel in Patients With Inoperable Stage III Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	UCCRC-11432 NCI-5411, NCT00042835, 5411

Trial Description

Purpose:

Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and radiation therapy with combination chemotherapy may kill more tumor cells.

Phase I trial to study the effectiveness of combining erlotinib and radiation therapy with combination chemotherapy in treating patients who have inoperable stage III non-small cell lung cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable or evaluable disease
• No previous chemotherapy for lung cancer
• No previous radiation therapy to the chest
• More than 3 weeks since surgery
• 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 be assigned to one of two groups. Patients in group one will receive a 2-hour infusion of cisplatin once a week in weeks 1, 2, 5, and 6 and a 1-hour infusion of etoposide once a day for 5 days in weeks 1 and 5. At the same time, they will also receive erlotinib by mouth once a day and will undergo radiation therapy 5 days a week for 7 weeks. Patients will then receive a 1-hour infusion of docetaxel in weeks 8, 11, and 14. Some patients may also receive erlotinib by mouth once a day in weeks 8-16. Patients in group two will receive a 1-hour infusion of paclitaxel and an infusion of carboplatin in weeks 1, 3, and 7-13 and erlotinib by mouth once a day in weeks 7-13. Patients will undergo radiation therapy 5 days a week for 7 weeks beginning in week 7. All patients will be evaluated at 8 weeks.

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

University of Chicago Cancer Research Center

Ann Mauer, MD, Protocol chair		Ph: 773-702-4138; 888-824-0200

Registry Information
Official Title		A Phase I Study Of OSI-774 (NSC #718781)-Based Multimodality Therapy For Inoperable Stage III Non Small Cell Lung Cancer
Trial Start Date		2002-05-23
Trial Completion Date		2008-12-22
Registered in ClinicalTrials.gov		NCT00042835
Date Submitted to PDQ		2002-06-03
Information Last Verified		2005-09-20
NCI Grant/Contract Number		N01-CM17102, P30-CA14599

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