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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00248547
First received: November 3, 2005
Last updated: December 20, 2011
Last verified: December 2011

November 3, 2005
December 20, 2011
May 2004
January 2009   (final data collection date for primary outcome measure)
Number of Emesis Free Participants During the Study Period. [ Time Frame: Up to three weeks ] [ Designated as safety issue: No ]
To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period
Not Provided
Complete list of historical versions of study NCT00248547 on ClinicalTrials.gov Archive Site
  • Safety in Transplant Population [ Time Frame: Up to three weeks ] [ Designated as safety issue: Yes ]
    To assess the safety of aprepitant in the bone marrow transplant population
  • Effects on Nausea, Appetite and Taste Changes [ Time Frame: Up to three weeks ] [ Designated as safety issue: No ]
    To assess the effects of aprepitant on nausea, appetite, and taste changes, (via visual analogue scale [VAS]), nutritional intake, and mucositis in the bone marrow transplant population.
  • Pharmacokinetic Interaction [ Time Frame: Up to three weeks ] [ Designated as safety issue: No ]
    To assess the potential for aprepitant and cyclophosphamide to interact pharmacokinetically in a significant manner to change blood levels of aprepitant, cyclophosphamide, hydroxycyclophosphamide or CEPM.
Not Provided
Not Provided
Not Provided
 
Aprepitant 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 Hematopoietic Cell Transplatation(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
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Cancer
  • Drug: aprepitant
    Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
    Other Name: Emend
  • Drug: dexamethasone
    For Cyclophosphamide Total Body Irradiation(CyTBI) patients: Dexamethasone study drug 1 capsule PO daily, 1 hour prior to chemotherapy with aprepitant on total body irradiation(TBI) and cyclophosphamide chemotherapy days; For Busulfan Cyclophosphamide(BuCy) patients: Dexamethasone 1 capsule orally once daily, discontinue after last dose of chemotherapy.
    Other Name: Decadron
  • Drug: ondansetron
    For CyTBI patients: Ondansetron 8 mg orally evert 12 hours, begin 1 hour prior to first TBI dose and discontinue after last dose; then Ondansetron 8 mg IV every 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy; For BuCy patients: Ondansetron 8 mg orally every 6 hours, begin 1 hour prior to first busulfan dose and discontinue after last busulfan dose is given. then: Ondansetron 8 mg IV Q 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy
    Other Name: Zofran
  • Drug: placebo
    Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
    Other Name: placebo, sugar pill
  • Active Comparator: Aprepitant
    Interventions:
    • Drug: aprepitant
    • Drug: dexamethasone
    • Drug: ondansetron
  • Placebo Comparator: sugar pill
    Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
    Interventions:
    • Drug: dexamethasone
    • Drug: ondansetron
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion:

  • 18 years of age or greater
  • must be scheduled for an autologous or allogeneic bone marrow or peripheral stem cell transplant
  • Eastern Cooperative Oncology Group(ECOG) performance status < or = 2
  • patients must have signed informed consent
  • must be able to swallow tablets and capsules
  • must be receiving a cyclophosphamide containing regimen.

Exclusion:

  • patient has known sensitivity to aprepitant, ondansetron, or dexamethasone
  • patient has received another investigational drug in the past 30 days
  • patient has had emesis or requires antiemetic agents in the 48 hours prior to beginning conditioning therapy
  • patient has taken neurokinin-1 antagonists for 14 days prior to enrollment
  • patient is pregnant, has a positive serum human chorionic gonadotropin(hCg) or is lactating
  • patient has serum creatinine level > or = 2*ULN
  • patient has severe hepatic insufficiency (Child-Pugh score >9)
  • patient drinks > 5 drinks/day for the last year
  • patient with concurrent illness requiring systemic corticosteroid use other than planned dexamethasone during conditioning 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
Yes
OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
Not Provided
Principal Investigator: Joseph Bubalo, PharmD OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
December 2011

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