Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Granisetron, Dexamethasone, Prochlorperazine, Aprepitant, and Palonosetron in Preventing Nausea in Women Undergoing Chemotherapy for 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

Objectives

Primary

1. Compare the efficacy of palonosetron hydrochloride and dexamethasone followed by prochlorperazine with vs without dexamethasone in preventing delayed nausea in women with chemotherapy-naive breast cancer. (Arms I and IV)
2. Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride in controlling anthracycline treatment-related delayed nausea in these patients. (Arms I and II)
3. Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for controlling anthracycline treatment-related delayed nausea in these patients. (Arms III and IV)

Secondary

1. Determine if the addition of dexamethasone to prochlorperazine is more effective than the same regimen without dexamethasone for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and IV)
2. Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and II)
3. Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for reducing interference with functioning due to chemotherapy-induced nausea and vomiting in these patients. (Arms III and IV)
4. Correlate sleep quality, physical exercise, and fatigue with chemotherapy-induced nausea in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of breast cancer
  • Chemotherapy-naive disease



• Must be scheduled to receive a chemotherapy treatment containing doxorubicin hydrochloride or epirubicin hydrochloride (any dose or schedule) without concurrent radiotherapy or interferon treatment
  • Chemotherapy may be for adjuvant, neoadjuvant, curative, or palliative intent
  • Dose-dense regimens allowed (e.g., doxorubicin hydrochloride or epirubicin hydrochloride given every 2 weeks)
    • No multiple-day doses of doxorubicin hydrochloride or epirubicin hydrochloride



• No symptomatic brain metastases



• Hormone receptor status not specified

Prior/Concurrent Therapy:

• See Disease Characteristics
• No concurrent pimozide, terfenadine, astemizole, or cisapride
• No concurrent doxorubicin hydrochloride liposome or cisplatin
• No concurrent multiple-day doses of dacarbazine, altretamine, nitrosoureas, or streptozocin
  • Multiple-day doses of other chemotherapy agents allowed

Patient Characteristics:

• Female
• Menopausal status not specified
• No concurrent or impending bowel obstruction
• Able to understand English

Expected Enrollment

A total of 890 patients will be accrued for this study.

Outcomes

Severity of delayed nausea
Interference with functioning caused by nausea or emesis

Change in quality of life score between pre- and post-treatment measurements

Outline

This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to CCOP center. Patients are randomized to 1 of 4 treatment arms. Patients receive study treatment approximately 30 minutes before their scheduled first chemotherapy treatment.

• Arm I: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.



• Arm II: Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.



• Arm III: Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.



• Arm IV: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.

Quality of life is assessed at baseline and on day 4. Nausea and vomiting, fatigue, sleep quality, exercise, and the need for rescue medication (metoclopramide) are assessed on days 1-4.

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.
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
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
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Joseph Roscoe, PhD	Ph:  585-275-5513
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		2008-12-07

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