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Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea

Primary Purpose

Nausea, Vomiting

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Standard PO (Zofran + Dexamethason)
Aprepitant (MK-869) + Standard PO
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea focused on measuring Bone Marrow Transplant, Nausea, Vomiting, NK-1 antagonist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of cancer, admitted for myelosupppresive stem cell transplantation. Included preparative regimens include: TBI/VP16/CY, TBI/CY, BU/CY (PO & IV), and BCV
  • Age 18 or older
  • Alcohol intake <100 gm/d for the last year (< approximately 5 drinks per day)
  • Renal function: estimated or measured CrCl 50 ml/min
  • Liver function: T.Bili <1.5, AST < 2x ULN, unless due to disease
  • Able to swallow tablets and capsules

Exclusion Criteria:

  • Age < 18
  • High alcohol intake [> 100 gm/d in the last year]
  • Allergy or intolerance to: ondansetron or dexamethasone
  • Renal dysfunction [measured or estimated CrCl < 50 ml/min]
  • Liver dysfunction [T.Bili > 1.5, AST > 2x ULN, unless due to disease]
  • Inability to swallow tablets or capsules
  • Concurrent condition requiring systemic steroid use
  • Nonmyeloablative SCT, patients receiving the conditioning regimens not included [see inclusion criteria]
  • History of anticipatory nausea and vomiting

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Standard PO (Zofran + Dexamethasone)

    Aprepitant (MK-869) + Standard PO

    Arm Description

    Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron (Zofran) 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion.

    Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO [blinded] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO [blinded] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.

    Outcomes

    Primary Outcome Measures

    Complete Response Rates Among Standard of Care and Combination Therapy Groups.
    Comparison of complete response (CR) rates between patients receiving ondansetron and dexamethasone and those receiving ondansetron and dexamethasone plus NK-1 antagonist, aprepitant. CR is defined as no emesis and with normal oral intake. Disease response not applicable.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 2008
    Last Updated
    June 29, 2018
    Sponsor
    Loyola University
    Collaborators
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00781768
    Brief Title
    Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea
    Official Title
    Prevention of Nausea and Vomitting Associated With Stem Cell Transplant: Results of a Prospective, Randomized Trial of Aprepitant Used With Highly Emetogenic Preparative Regimens
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2003 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    July 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Loyola University
    Collaborators
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare two different treatment protocols for treating nausea and vomiting in patients who have undergone bone marrow transplant. Patients will be assigned to one of two treatment groups. The first group will recieve ondansetron (Zofran) tablets combined with a medicine called dexamethasone given IV. Both of these drugs are commercially available. Patients in the second treatment consists of the first two drugs, plus a newly approved drug known as aprepitant (MK-869, Emend). This combination will be the treatment being tested. The combination is approved by the FDA for chemotherapy regimens known to cause a lot of nausea and vomiting. It significantly decreases the delayed (more than 24 hours after therapy) nausea and vomiting seen with these regimens.
    Detailed Description
    This will be a single center, comparative, randomized, double-blind, phase III trial designed to evaluate the efficacy of the NK-1 antagonist, aprepitant (MK-869), in combination with ondansetron and dexamethasone in the prevention of acute and delayed nausea and vomiting compared to ondansetron and dexamethasone in patients receiving highly emetogenic preparative regimens prior to autologous or allogeneic (related and unrelated) stem cell transplantation. Patients will be randomized to one of two treatments: dexamethasone 10 mg IV once daily and ondansetron 8 mg orally every 8 hours on each day of the preparative regimen plus one additional day vs. 7.5 mg IV once daily and ondansetron 8 mg orally every 8 hours on each day of the preparative regimen plus one additional day combined with aprepitant, 125 mg orally on the first day of their preparative regimen followed by 80 mg daily on each remaining day of the preparative regimen plus three additional days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nausea, Vomiting
    Keywords
    Bone Marrow Transplant, Nausea, Vomiting, NK-1 antagonist

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    181 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard PO (Zofran + Dexamethasone)
    Arm Type
    Placebo Comparator
    Arm Description
    Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron (Zofran) 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion.
    Arm Title
    Aprepitant (MK-869) + Standard PO
    Arm Type
    Active Comparator
    Arm Description
    Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO [blinded] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO [blinded] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
    Intervention Type
    Drug
    Intervention Name(s)
    Standard PO (Zofran + Dexamethason)
    Other Intervention Name(s)
    Ondansetron (Zofran)
    Intervention Description
    Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
    Intervention Type
    Drug
    Intervention Name(s)
    Aprepitant (MK-869) + Standard PO
    Other Intervention Name(s)
    Ondansetron + Dexamethason (Standard PO)
    Intervention Description
    Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO [blinded] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO [blinded] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
    Primary Outcome Measure Information:
    Title
    Complete Response Rates Among Standard of Care and Combination Therapy Groups.
    Description
    Comparison of complete response (CR) rates between patients receiving ondansetron and dexamethasone and those receiving ondansetron and dexamethasone plus NK-1 antagonist, aprepitant. CR is defined as no emesis and with normal oral intake. Disease response not applicable.
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of cancer, admitted for myelosupppresive stem cell transplantation. Included preparative regimens include: TBI/VP16/CY, TBI/CY, BU/CY (PO & IV), and BCV Age 18 or older Alcohol intake <100 gm/d for the last year (< approximately 5 drinks per day) Renal function: estimated or measured CrCl 50 ml/min Liver function: T.Bili <1.5, AST < 2x ULN, unless due to disease Able to swallow tablets and capsules Exclusion Criteria: Age < 18 High alcohol intake [> 100 gm/d in the last year] Allergy or intolerance to: ondansetron or dexamethasone Renal dysfunction [measured or estimated CrCl < 50 ml/min] Liver dysfunction [T.Bili > 1.5, AST > 2x ULN, unless due to disease] Inability to swallow tablets or capsules Concurrent condition requiring systemic steroid use Nonmyeloablative SCT, patients receiving the conditioning regimens not included [see inclusion criteria] History of anticipatory nausea and vomiting
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrick Stiff, MD
    Organizational Affiliation
    Loyola University Cardinal Bernadin Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea

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