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

Alternate Title

Phase III Randomized Study of Polyglutamate Paclitaxel (CT-2103) Versus Docetaxel as Second-Line Therapy in Patients With Progressive Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Pharmaceutical / Industry	CTI-PGT302 CWRU-CTI-1503, NCT00054184

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether polyglutamate paclitaxel is more effective than docetaxel in treating non-small cell lung cancer.

Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel with that of docetaxel in treating patients who have progressive non-small cell lung cancer.

Eligibility:

• At least 18 years old
• No previous polyglutamate paclitaxel
• No previous docetaxel
• More than 2 weeks since treatment for non-small cell lung 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 be randomly assigned to one of two groups. Patients in group one will receive an infusion of polyglutamate paclitaxel. Patients in group two will receive a 1-hour infusion of docetaxel. Treatment in both groups may be repeated every 3 weeks for as long as benefit is shown. Patients will be evaluated at 3 weeks and every 8 weeks 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

Cell Therapeutics, Incorporated

Brenda Garrison, Protocol chair		Ph: 910-772-6952

Registry Information
Official Title		CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer (NSCLC): A Phase III Study
Trial Start Date		2003-01-15
Registered in ClinicalTrials.gov		NCT00054184
Date Submitted to PDQ		2002-12-23
Information Last Verified		2004-07-26
NCI Grant/Contract Number		CA43703

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