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

Alternate Title

Phase I Randomized Study of Irinotecan and Thalidomide in Patients With Advanced Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	UCCRC-12044B NCI-5814, NCT00062127, 5814

Trial Description

Purpose:

Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill more tumor cells.

This randomized phase I trial is studying the side effects and best way to give irinotecan and thalidomide in treating patients with metastatic or unresectable solid tumors.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable or evaluable disease
• Not pregnant or nursing
• At least 4 weeks since biological therapy, chemotherapy, or radiation therapy
• More than 4 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 randomly assigned to one of two groups.

Patients in group one will receive a 1.5-hour infusion of irinotecan in weeks 1 and 4. They will also receive thalidomide by mouth once a day in weeks 3-4.

Patients in group two will receive thalidomide by mouth once a day for 2 weeks. They will also receive a 1.5-hour infusion of irinotecan in weeks 2 and 5.

All patients will be evaluated at 6 weeks. Patients may receive additional irinotecan once every 3 weeks and thalidomide once a day for as long as benefit is shown.

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

Apurva Desai, Protocol chair		Ph: 773-702-9200; 888-824-0200

Registry Information
Official Title		A Phase I Pharmacokinetic Interaction Study of Irinotecan (NSC616348) and Thalidomide (NSC66847) in Patients with Advanced Solid Tumors
Trial Start Date		2003-04-29
Registered in ClinicalTrials.gov		NCT00062127
Date Submitted to PDQ		2003-04-24
Information Last Verified		2005-06-02
NCI Grant/Contract Number		CA69852, CA14599

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