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

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.

Study Type: Interventional

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

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.

Intervention(s) in this Clinical Trial

• Drug: aprepitant
• Drug: dexamethasone
• Drug: ondansetron

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Oregon Health and Science University Cancer Institute

Overall Clinical Trial Officials and Contacts

Joseph Bubalo, PharmD, BCPS, BCOP Study Chair Oregon Health and Science University Cancer Institute  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00248547

Study ID Number: CDR0000445452

ClinicalTrials.gov Identifier: NCT00248547

Health Authority: United States: Federal Government

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