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

Alternate Title

Phase I/II Study of E7389 in Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Renal Insufficiency

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI	CCC-PHII-75 7435, NCI-7435, NCT00365157

Trial Description

Purpose:

Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.

This phase I/II trial is studying the side effects and best dose of E7389 and to see how well it works in treating patients with locally advanced or metastatic cancer of the urothelium and kidney dysfunction.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• 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 E7389 once a week for 2 weeks. Treatment may repeat every 3 weeks for as long as benefit is shown.

Some patients will undergo blood collection periodically during course one for laboratory studies.

After finishing treatment, patients will be evaluated periodically for at least 6 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

California Cancer Consortium

David Quinn, MD, Protocol chair		Ph: 323-865-3956; 800-865-0102 Email: diquinn@hsc.usc.edu

U.S.A.
California
	Beverly Hills
	Tower Cancer Research Foundation
		Solomon Hamburg, MD, PhD	Ph:  310-888-8680
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Center	Ph:  800-826-4673
			Email: becomingapatient@coh.org
	Martinez
	Contra Costa Regional Medical Center
		Sharon Hiner, MD	Ph:  925-370-5114 800-232-4636
			Email: shiner@hsd.co.contra-costa.ca.us
	Veterans Affairs Outpatient Clinic - Martinez
		Nelson Lim, MD	Ph:  925-372-2062
			Email: nelson.lim@med.va.gov
	Pasadena
	City of Hope Medical Group
		Mark McNamara, MD	Ph:  626-396-2900
			Email: mmcnamara@ccsmg.com
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-6601
	Evanston
	Evanston Northwestern Healthcare - Evanston Hospital
		Clinical Trials Office - Evanston Northwestern Healthcare - Evanston Hospital	Ph:  847-570-1381
	Harvey
	Ingalls Cancer Care Center at Ingalls Memorial Hospital
		Clinical Trials Office - Ingalls Cancer Care Center at Ingalls Memorial Hospital	Ph:  708-915-6747
	Joliet
	Joliet Oncology-Hematology Associates, Limited - West
		Sanjiv Modi, MD	Ph:  815-730-3098
			Email: smod@jolietoncology.com
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
	Peoria
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		Sachdev Thomas, MD	Ph:  309-243-1000
			Email: sthomas@ohaci.com
	Springfield
	Central Illinois Hematology Oncology Center
		Edem Agamah, MD, MS	Ph:  217-525-2500
			Email: ihdn@aol.com
Indiana
	Fort Wayne
	Fort Wayne Medical Oncology and Hematology
		Sreenivasa Nattam, MD	Ph:  260-484-8830 800-852-2333
			Email: ledgar@fwmoh.com
	South Bend
	CCOP - Northern Indiana CR Consortium
		David Taber, MD	Ph:  574-647-3353 800-284-7370
Maryland
	Baltimore
	Greenebaum Cancer Center at University of Maryland Medical Center
		Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center	Ph:  800-888-8823
Michigan
	Ann Arbor
	University of Michigan Comprehensive Cancer Center
		Clinical Trials Office - University of Michigan Comprehensive Cancer Center	Ph:  800-865-1125
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
	Saint Joseph
	Oncology Care Associates, PLLC
		Eric Lester, MD	Ph:  269-985-0029
Missouri
	Saint Louis
	David C. Pratt Cancer Center at St. John's Mercy
		Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy	Ph:  314-251-6770
Pennsylvania
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center	Ph:  717-531-3779
			Email: CTO@hmc.psu.edu
	Pittsburgh
	UPMC Cancer Centers
		Clinical Trials Office - UPMC Cancer Centers	Ph:  412-647-8073
Wisconsin
	Milwaukee
	Medical College of Wisconsin Cancer Center
		Clinical Trials Office - Medical College of Wisconsin Cancer Center	Ph:  414-805-4380

Registry Information
Official Title		A Phase I/II Study of E7389 Halichondrin B Analog (NSC #707389; IND #64395) in Metastatic Urothelial Tract Cancer and Renal Insufficiency
Trial Start Date		2006-10-23
Trial Completion Date		2008-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00365157
Date Submitted to PDQ		2006-06-19
Information Last Verified		2008-12-07
NCI Grant/Contract Number		CA62505