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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 Flavopiridol, Gemcitabine, and Irinotecan in Patients With Unresectable or Metastatic Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	UNM-0903C NCI-6415, 6415, NCT00079352

Trial Description

Purpose:

Drugs used in chemotherapy, such as flavopiridol, gemcitabine, and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

This phase I trial is studying the side effects and best dose of flavopiridol when given together with gemcitabine and irinotecan in treating patients with unresectable or metastatic solid tumors.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No brain metastases
• More than 4 weeks since chemotherapy 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 an infusion of gemcitabine and an infusion of irinotecan on days 1 and 15. They will also receive a 1-hour infusion of flavopiridol on days 2 and 16. Treatment may be repeated every 4 weeks for up to six courses.

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 New Mexico Cancer Center

Ian Rabinowitz, MD, Protocol chair		Ph: 505-272-4551 Email: irabinowitz@salud.unm.edu

Registry Information
Official Title		A Phase I Study of Flavopiridol in Combination With Gemcitabine and Irinotecan in Patients With Metastatic Cancer
Trial Start Date		2004-03-23
Trial Completion Date		2007-10-01
Registered in ClinicalTrials.gov		NCT00079352
Date Submitted to PDQ		2004-02-02
Information Last Verified		2007-06-13

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