Full Text View
Tabular View
No Study Results Posted
Related Studies
Aprepitant, Ondansetron, and Dexamethasone in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant
This study is ongoing, but not recruiting participants.
Study NCT00248547   Information provided by National Cancer Institute (NCI)
First Received: November 3, 2005   Last Updated: April 4, 2009   History of Changes

November 3, 2005
April 4, 2009
May 2004
 
 
 
Complete list of historical versions of study NCT00248547 on ClinicalTrials.gov Archive Site
 
 
 
Aprepitant, Ondansetron, and Dexamethasone in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant
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.

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.

 
Interventional
Supportive Care, Randomized, Single Blind, Placebo Control
Cancer
  • Drug: aprepitant
  • Drug: dexamethasone
  • Drug: ondansetron
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
40
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00248547
 
CDR0000445452, OHSU-HEM-03074-L, OHSU-1057, MERCK-OHSU-HEM-03074-L
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Study Chair: Joseph Bubalo, PharmD, BCPS, BCOP OHSU Knight Cancer Institute
National Cancer Institute (NCI)
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP