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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 UCN-01 and Irinotecan in Patients With Advanced Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	JHOC-J0173 NCI-5528, NCT00047242, 5528

Trial Description

Purpose:

UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells.

Phase I trial to study the effectiveness of combining UCN-01 with irinotecan in treating patients who have advanced solid tumors.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No brain metastases
• At least 4 weeks since chemotherapy or radiation therapy
• No previous radiation therapy to the mediastinum
• 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 3-hour infusion of UCN-01 on day 1 and a 90-minute infusion of irinotecan on days 1 and 8. Treatment may be repeated every 3 weeks for as long as benefit is shown. Patients will be evaluated at 1 month.

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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Ross Donehower, MD, Protocol chair		Ph: 410-955-8838 Email: donehro@jhmi.edu

Registry Information
Official Title		The Pharmacokinetic and Safety Profile of UCN-01 in Combination with Irinotecan in Solid Tumors (Primarily Lung, Ovarian and GI Cancers)
Trial Start Date		2002-08-19
Trial Completion Date		2006-02-23
Registered in ClinicalTrials.gov		NCT00047242
Date Submitted to PDQ		2002-08-15
Information Last Verified		2006-04-08
NCI Grant/Contract Number		U01-CA70095, P30-CA06973

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