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

Alternate Title

Phase II Randomized Study of Monoclonal Antibody ABX-EGF, Carboplatin, and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI, Pharmaceutical / Industry	UCLA-0304051 IMMUNEX-054.0004, ABX-0304, AMGEN-20025404, NCT00034346

Trial Description

Purpose:

Monoclonal antibodies 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 carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

Randomized phase II trial to study the effectiveness of combining a monoclonal antibody with carboplatin and paclitaxel in treating patients who have advanced non-small cell lung cancer.

Eligibility:

• At least 18 years old
• Measurable disease
• More than 2 weeks since radiation therapy
• 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 1-hour infusion of the monoclonal antibody once a week for 6 weeks. They will also receive a 3-hour infusion of paclitaxel and an infusion of carboplatin in weeks 1 and 4. Patients will then be randomly assigned to one of two groups.

Patients in group one will receive infusions of paclitaxel and carboplatin alone as above.

Patients in group two will receive infusions of the monoclonal antibody, paclitaxel, and carboplatin as above. Some patients may continue to receive monoclonal antibody, paclitaxel, and carboplatin every 3 weeks for up to four courses.

Quality of life will be assessed periodically. Patients will be evaluated within 1 month and every 3 months for 2 years.

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

Jonsson Comprehensive Cancer Center at UCLA

Diane Prager, MD, Principal investigator(Contact information may not be current)		Ph: 310-825-5268; 888-798-0719

Registry Information
Official Title		A Two Part, Multiple Dose Clinical Trial Of The Safety And Efficacy Of ABX-EGF In Combination With Paclitaxel And Carboplatin In Patients With Advanced Non-Small Cell Lung Cancer
Trial Completion Date		2007-12-20
Registered in ClinicalTrials.gov		NCT00034346
Date Submitted to PDQ		2003-07-28
Information Last Verified		2004-05-18
NCI Grant/Contract Number		CA16042

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