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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 Sunitinib Malate, Cisplatin, and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	18 and over	NCI	CALGB-30504 CALGB 30504, NCT00453154

Trial Description

Purpose:

Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib together with cisplatin and etoposide may kill more tumor cells.

This phase I/II trial is studying the side effects and best dose of sunitinib when given together with cisplatin and etoposide and to see how well they work in treating patients with extensive-stage small cell lung cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• No brain metastases
• No spinal cord compression or carcinomatous meningitis
• No previous chemotherapy for small cell lung cancer
• 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:

Some patients will receive an infusion of cisplatin on day 1 and an infusion of etoposide on days 1-3. They will also receive sunitinib by mouth once a day for 2 weeks. Treatment may repeat every 3 weeks for up to six courses. Patients will then receive sunitinib alone by mouth once a day for as long as benefit is shown.

Patients will receive an infusion of cisplatin on day 1, an infusion of etoposide on days 1-3, and sunitinib by mouth once a day for 2 weeks. Treatment with cisplatin, etoposide, and sunitinib may repeat every 3 weeks for up to six courses.

Some patients will be randomly assigned (have and equal chance of being placed) to one of two treatment groups.

Patients in group one will receive sunitinib by mouth once a day on day 1 for as long as benefit is shown.

Patients in group two will receive placebo by mouth once a day on day 1 for as long as benefit is shown.

After finishing treatment, patients will be evaluated every 3 months for 1 year and every 6 months for 2 years.

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

Cancer and Leukemia Group B

Neal Ready, MD, PhD, Protocol chair		Ph: 919-681-6932 Email: ready007@mc.duke.edu

U.S.A.
California
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-733-6227
Georgia
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute	Ph:  912-350-8568
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	La Grange
	La Grange Memorial Hospital
		Clinical Trials Office - La Grange Memorial Hospital	Ph:  630-856-7526
Indiana
	Elkhart
	Elkhart General Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Kokomo
	Howard Community Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	South Bend
	CCOP - Northern Indiana CR Consortium
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
	Saint Joseph Regional Medical Center
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Maryland
	Elkton MD
	Union Hospital Cancer Program at Union Hospital
		Stephen Grubbs, MD	Ph:  302-366-1200
	Salisbury
	Peninsula Regional Medical Center
		Clinical Trials Office - Peninsula Regional Medical Center	Ph:  410-543-7000
Massachusetts
	Gloucester
	Addison Gilbert Hospital
		Angus McIntyre, MD	Ph:  978-927-6850
Michigan
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Missouri
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Maria Baggstrom, MD	Ph:  314-362-5737
Nebraska
	Grand Island
	Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
		Apar Ganti	Ph:  308-398-5450 800-998-2119
	North Platte
	Callahan Cancer Center at Great Plains Regional Medical Center
		Clinical Trials Office - Callahan Cancer Center at Great Plains Regional Medical Center	Ph:  308-696-7864
	Omaha
	Alegant Health Cancer Center at Bergan Mercy Medical Center
		Clinical Trials Office - Alegant Health Cancer Center at Bergen Mercy Medical Center	Ph:  402-398-6060
	CCOP - Missouri Valley Cancer Consortium
		Gamini Soori, MD, FACP, FRCP, MBA	Ph:  402-393-3110
	Creighton University Medical Center
		Clinical Trials Office - Creighton University Medical Center	Ph:  402-280-4100
	Immanuel Medical Center
		Gamini Soori, MD, FACP, FRCP, MBA	Ph:  402-393-3110
	Methodist Estabrook Cancer Center
		Robert Langdon, MD	Ph:  402-399-8762
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Ph:  800-999-5465
New Hampshire
	Concord
	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
		Charles Catcher, MD	Ph:  603-224-2556
	Hooksett
	New Hampshire Oncology - Hematology, PA - Hooksett
		Charles Catcher, MD	Ph:  603-224-2556
New Jersey
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
New York
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	Glens Falls
	Charles R. Wood Cancer Center at Glens Falls Hospital
		Clinical Trials Office - Charles R. Wood Cancer Center at Glens Falls Hospital	Ph:  518-926-6700
	New York
	Memorial Sloan-Kettering Cancer Center
		Lee Krug, MD	Ph:  212-639-8420
	Syracuse
	SUNY Upstate Medical University Hospital
		Clinical Trials Office - SUNY Upstate Medical University Hospital	Ph:  315-464-5476
North Carolina
	Durham
	Duke Comprehensive Cancer Center
		Clinical Trials Office - Duke Comprehensive Cancer Center	Ph:  888-275-3853
	Hendersonville
	Pardee Memorial Hospital
		James Radford, MD	Ph:  828-692-8045
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
Ohio
	Columbus
	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: osu@emergingmed.com
South Carolina
	Florence
	McLeod Regional Medical Center
		Clinical Trials Office - McLeod Regional Medical Center	Ph:  843-679-7256
Vermont
	Berlin
	Mountainview Medical
		Steven Grunberg, MD	Ph:  802-847-3827
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
Virginia
	Danville
	Danville Regional Medical Center
		Clinical Trials Office - Danville Regional Medical Center	Ph:  434-799-3753

Registry Information
Official Title		Combination Cisplatin, Etoposide and Sunitinib Malate (IND 74019; NSC 736511) For Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/II Study
Trial Start Date		2007-03-15
Trial Completion Date		2008-02-23 (estimated)
Registered in ClinicalTrials.gov		NCT00453154
Date Submitted to PDQ		2007-02-26
Information Last Verified		2009-05-07
NCI Grant/Contract Number		CA31946