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

Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer

Intervention: aprepitant (Drug); dexamethasone (Drug); ondansetron (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Oregon Health and Science University Cancer Institute

Official(s) and/or principal investigator(s):
Joseph Bubalo, PharmD, BCPS, BCOP, Study Chair, Affiliation: Oregon Health and Science University Cancer Institute

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.

Clinical Details

Official title: A Pilot Study of Aprepitant vs. Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During HCT

Study design: Supportive Care, Randomized, Single Blind, Placebo Control

Detailed description: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Oregon Health & Science University Cancer Institute, Portland, Oregon 97239-3098, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: May 2004
Last updated: May 23, 2008

Page last updated: June 20, 2008

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