Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Closed	18 and over	NCI, Other	CDR0000445452 OHSU-HEM-03074-L, OHSU-1057, MERCK-OHSU-HEM-03074-L, NCT00248547

Trial Description

Summary

RATIONALE: Antiemetic drugs, such as aprepitant, ondansetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant.

PURPOSE: This randomized clinical trial is studying aprepitant, ondansetron, and dexamethasone to see how well they work compared to placebo, ondansetron, and dexamethasone in preventing nausea and vomiting in patients who are undergoing a stem cell transplant.

Further Study Information

OBJECTIVES:

Primary

• 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

• Determine the safety of aprepitant in these patients.

• Compare nausea, appetite, taste changes, nutritional intake, and mucositis in patients treated with these regimens.

• Determine the pharmacokinetics of cyclophosphamide, carboxyethylphosphoramide mustard, hydroxycyclophylamide, and aprepitant in these patients.

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.

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

Eligibility Criteria

DISEASE CHARACTERISTICS:

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

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Knight Cancer Institute at Oregon Health and Science University

Joseph Bubalo, PharmD, BCPS, BCOP

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00248547
Information obtained from ClinicalTrials.gov on September 16, 2009

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