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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 GTI-2040 and Docetaxel in Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors (Phase I study closed to accrual as of 8/5/2004)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	18 and over	NCI	PMH-PHL-017 NCI-6104, NCT00074022, 6104

Trial Description

Purpose:

GTI-2040 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of docetaxel by making the tumor cells more sensitive to the drug. Combining GTI-2040 with docetaxel may kill more tumor cells

Phase I/II trial to study the effectiveness of combining GTI-2040 with docetaxel in treating patients who have recurrent, metastatic, or unresectable locally advanced non-small cell lung cancer, prostate cancer, or other solid tumors.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• No primary bone cancer
• More than 4 weeks since chemotherapy, hormone therapy, or 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 2-week continuous infusion of GTI-2040. They will also receive a 1-hour infusion of docetaxel on day 3 in course one and on day 1 in all subsequent courses. Treatment may be repeated every 3 weeks for as long as benefit is shown. Patients will be evaluated every 3 months.

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

Princess Margaret Hospital

Natasha Leighl, MD, FRCPC, Protocol chair		Ph: 416-946-2399

Registry Information
Official Title		A Phase I/2 Study of GTI-2040 Combined With Docetaxel In Metastatic Or Unresectable Locally Advanced Non-Small Cell Lung Cancer
Trial Start Date		2003-11-28
Registered in ClinicalTrials.gov		NCT00074022
Date Submitted to PDQ		2003-10-22
Information Last Verified		2006-09-25
NCI Grant/Contract Number		CM17107

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