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

Alternate Title

Aprepitant, Ondansetron, and Dexamethasone in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Closed 18 and over NCI, Pharmaceutical / Industry OHSU-HEM-03074-L OHSU-1057, MERCK-OHSU-HEM-03074-L, NCT00248547

Objectives

Primary

1. Compare the efficacy of standard antiemetic therapy comprising ondansetron and dexamethasone combined with either aprepitant or placebo in controlling nausea and vomiting, as determined by the number of retch/emesis-free days, in patients undergoing hematopoietic stem cell transplantation.

Secondary

1. Determine the safety of aprepitant in these patients.
2. Compare nausea, appetite, taste changes, nutritional intake, and mucositis in patients treated with these regimens.
3. Determine the pharmacokinetics of cyclophosphamide, carboxyethylphosphoramide mustard, hydroxycyclophylamide, and aprepitant in these patients.

Entry Criteria

Disease Characteristics:

• Planning to undergo autologous or allogeneic bone marrow or peripheral blood stem cell transplantation AND receive a cyclophosphamide-containing conditioning regimen

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics

Endocrine therapy

• No other concurrent systemic corticosteroids

Chemotherapy

• See Disease Characteristics

Other

• More than 30 days since prior investigational drugs
• More than 48 hours since prior antiemetic agents
• More than 14 days since prior neurokinin-1 antagonist therapy

Patient Characteristics:

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No severe hepatic insufficiency (Child-Pugh score > 9)

Renal

• Creatinine < 2 times upper limit of normal

Other

• Not pregnant or nursing
• Negative pregnancy test
• Able to swallow oral medications
• No known sensitivity to aprepitant, ondansetron, or dexamethasone
• No emesis within the past 48 hours
• No alcohol use > 5 drinks/day within the past year
• No other illness requiring systemic corticosteroid use

Expected Enrollment

A total of 40 patients (20 per treatment arm) will be accrued for this study.

Outline

This is a randomized, placebo-controlled, single-blind, pilot study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Beginning on the first day of conditioning chemotherapy, patients receive oral aprepitant once daily and standard antiemetic therapy comprising oral or IV ondansetron and oral dexamethasone.



• Arm II: Patients receive oral placebo once daily and standard antiemetic therapy as in arm I.

In both arms, treatment continues until day 4 after stem cell transplant in the absence of unacceptable toxicity.

After completion of study therapy, patients are followed until day 18.

Trial Contact Information

Trial Lead Organizations

Oregon Health and Science University Cancer Institute

Joseph Bubalo, PharmD, BCPS, BCOP, Protocol chair		Ph: 503-494-8007; 800-494-1234 Email: bubaloj@ohsu.edu

Registry Information
Official Title		A Pilot Study of Aprepitant vs. Placebo Combined with Standard Antiemetics for the Control of Nausea and Vomiting During HCT
Trial Start Date		2004-05-13
Registered in ClinicalTrials.gov		NCT00248547
Date Submitted to PDQ		2005-08-19
Information Last Verified		2006-09-17
NCI Grant/Contract Number		CA69533

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