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

Alternate Title

Phase III Randomized Study of Different Combinations of Granisetron Hydrochloride, Dexamethasone, Prochlorperazine, Aprepitant, and Palonosetron Hydrochloride in Preventing Delayed Nausea in Patients Undergoing Chemotherapy for Chemotherapy-Naive Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Active	18 and over	NCI	URCC-04-02 URCC 0402, URCC-U1105, U1105, NCT00475085

Special Category: NCI Web site featured trial

Trial Description

Purpose:

Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which combination of antiemetic drugs is more effective in preventing nausea caused by chemotherapy.

This randomized phase III trial is comparing different combinations of granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in preventing nausea in patients undergoing chemotherapy for breast cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Breast cancer has not been treated with chemotherapy
• Scheduled to receive doxorubicin, epirubicin, cisplatin, carboplatin, or oxaliplatin without radiation therapy or interferon
• Understands English
• 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 (have an equal chance of being placed) to one of four treatment groups. Patients will begin treatment approximately 30 minutes before their first chemotherapy treatment.

Patients in group one will receive infusions of palonosetron and dexamethasone and a placebo by mouth once on day 1. They will also receive prochlorperazine by mouth three times a day and a different placebo by mouth once a day on days 2 and 3.

Patients in group two will receive infusions of granisetron and dexamethasone and a placebo by mouth once on day 1. They will also receive prochlorperazine by mouth three times a day and a different placebo by mouth once a day on days 2 and 3.

Patients in group three will receive infusions of palonosetron and dexamethasone once on day 1. They will also receive aprepitant by mouth once a day on days 1-3, and dexamethasone by mouth once a day and a placebo by mouth twice a day on days 2 and 3.

Patients in group four will receive infusions of palonosetron and dexamethasone and a placebo by mouth once on day 1. They will also receive prochlorperazine by mouth three times a day and dexamethasone by mouth once a day on days 2 and 3.

Quality of life will be assessed at the beginning of the study and on day 4. Nausea and vomiting, fatigue, sleep quality, exercise, and the need for metoclopramide will be assessed on days 1-4.

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 Rochester Cancer Center CCOP Research Base

Joseph Roscoe, PhD, Principal investigator		Ph: 585-275-5513

U.S.A.
Alabama
	Mobile
	MBCCOP - Gulf Coast
		Thaddeus Beeker, MD	Ph:  251-631-3542
Illinois
	Decatur
	CCOP - Central Illinois
		James Wade, MD	Ph:  217-876-6618
			Email: peggyv@dmhhs.org
Kansas
	Wichita
	CCOP - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-268-5784 800-362-5784
			Email: marge_good@via-christi.org
Michigan
	Grand Rapids
	CCOP - Grand Rapids
		Marianne Lange, MD	Ph:  616-391-1230
			Email: connie.szczepanek@grcop.org
	Kalamazoo
	CCOP - Kalamazoo
		Raymond Lord, MD	Ph:  269-373-7458
			Email: rlord@wmcc.org
Minnesota
	St. Louis Park
	CCOP - Metro-Minnesota
		Patrick Flynn, MD	Ph:  952-993-1576
			Email: hillre@parknicollet.com
Missouri
	Kansas City
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  816-823-0555
			Email: leslie.herst@hcamidwest.com
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		John Ellerton, MD, CM	Ph:  702-384-0013
			Email: k.vanwagenen@sncrf.org
New York
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
			Email: csweeney@hoacny.com
	Manhassett
	CCOP - North Shore University Hospital
		Vincent Vinciguerra, MD	Ph:  516-734-8918
			Email: nnier@nshs.edu
North Carolina
	Goldsboro
	CCOP - Southeast Cancer Control Consortium
		James Atkins, MD	Ph:  336-777-3036
			Email: rburgess@wfubmc.edu
Ohio
	Columbus
	CCOP - Columbus
		J. Philip Kuebler, MD, PhD	Ph:  614-488-2647
			Email: debby@mail.columbus-ccop.org
	Dayton
	CCOP - Dayton
		Howard Gross, MD	Ph:  937-395-8679
			Email: bernadette.bensman@wright.edu
South Carolina
	Greenville
	CCOP - Greenville
		Jeffrey Giguere, MD, FACP	Ph:  864-241-6251
			Email: lyndon.evans@usoncology.com
Washington
	Tacoma
	CCOP - Northwest
		Lauren Colman, MD	Ph:  253-403-1461
			Email: karyn.hart@multicare.org
Wisconsin
	Marshfield
	CCOP - Marshfield Clinic Research Foundation
		Tarit Banerjee, MD, FACP	Ph:  715-389-5592
			Email: banerjee.tarit@marshfieldclinic.org

Related Information

Featured trial article

Registry Information
Official Title		Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial
Trial Start Date		2006-12-13
Trial Completion Date		2010-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00475085
Date Submitted to PDQ		2007-04-24
Information Last Verified		2009-06-14
NCI Grant/Contract Number		CA37420

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