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Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer

Primary Purpose

Myeloproliferative Disorders, Leukemia, Lymphoma

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
aprepitant
ondansetron hydrochloride
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myeloproliferative Disorders focused on measuring unspecified adult solid tumor, protocol specific, nausea and vomiting, chronic myelogenous leukemia, chronic eosinophilic leukemia, chronic idiopathic myelofibrosis, chronic neutrophilic leukemia, essential thrombocythemia, polycythemia vera, adult acute lymphoblastic leukemia, adult acute myeloid leukemia, acute undifferentiated leukemia, mast cell leukemia, adult T-cell leukemia/lymphoma, T-cell large granular lymphocyte leukemia, chronic lymphocytic leukemia, hairy cell leukemia, prolymphocytic leukemia, AIDS-related lymphoma, adult Hodgkin lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, cutaneous B-cell non-Hodgkin lymphoma, cutaneous T-cell non-Hodgkin lymphoma, mycosis fungoides/Sezary syndrome, adult grade III lymphomatoid granulomatosis, adult nasal type extranodal NK/T-cell lymphoma, Waldenstrom macroglobulinemia, adult Burkitt lymphoma, adult diffuse large cell lymphoma, adult diffuse mixed cell lymphoma, adult diffuse small cleaved cell lymphoma, adult immunoblastic large cell lymphoma, adult lymphoblastic lymphoma, grade 1 follicular lymphoma, grade 2 follicular lymphoma, grade 3 follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, small lymphocytic lymphoma, intraocular lymphoma, primary central nervous system lymphoma, post-transplant lymphoproliferative disorder, multiple myeloma and other plasma cell neoplasms, myelodysplastic syndromes, atypical chronic myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, chronic myeloproliferative disorders, myelodysplastic/myeloproliferative diseases

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • History of malignancy (including hematological malignancies)
  • Has pain requiring opioid analgesics
  • Nausea and vomiting (associated with opioid analgesic use) that is unrelieved by at least one standard antiemetic regimen (including 5HT3 antagonist and dexamethasone combination therapy)

    • Patients who have failed ondansetron hydrochloride for treatment of opioid-induced nausea and vomiting will be excluded from the study

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Able to assess severity of nausea and vomiting and document it in the diary
  • Women must not be pregnant or lactating
  • Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
  • Urine pregnancy test will be given to women of childbearing age
  • No concerns about compliance with medication regimen or medical follow-up (patient must be able to tolerate oral dosing)
  • No severe or chronic illness or other causes of nausea and vomiting, that in judgment of the treating physician, will place patient at risk
  • No severe gastrointestinal obstruction or active peptic ulcer disease
  • Serum ALT and AST < 2 times upper limit of normal (ULN)
  • Serum bilirubin < 2 times ULN
  • Serum alkaline phosphatase < 2 times ULN

PRIOR CONCURRENT THERAPY:

  • No surgery within the past 7 days
  • No chemotherapy within the past 7 days
  • No total or lower body radiation therapy within the past 7 days
  • Patient may not be scheduled to undergo total body irradiation or lower body irradiation, chemotherapy, or surgery during study participation
  • Patient must not be taking warfarin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    ARM A

    ARM B

    Arm Description

    Outcomes

    Primary Outcome Measures

    Control of nausea and vomiting

    Secondary Outcome Measures

    Quality of life
    Pain control
    Mood
    Global satisfaction

    Full Information

    First Posted
    July 10, 2007
    Last Updated
    March 29, 2013
    Sponsor
    Vanderbilt-Ingram Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00499668
    Brief Title
    Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer
    Official Title
    A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    slow accrual
    Study Start Date
    August 2007 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt-Ingram Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: Antiemetic drugs, such as aprepitant and ondansetron, may help lessen nausea and vomiting caused by opioids. It is not yet known whether aprepitant is more effective than ondansetron in treating nausea and vomiting caused by opioids in patients with cancer. PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works compared to ondansetron in treating nausea and vomiting caused by opioids in patients with cancer.
    Detailed Description
    OBJECTIVES: Primary To evaluate the efficacy of aprepitant as monotherapy for opioid-induced nausea and vomiting (OINV) in comparison to ondansetron hydrochloride in patients who have failed at least one prior anti-emetic agent/regimen. Secondary To determine whether control of OINV improves quality of life. To determine if control in OINV decreases pain. To determine if control in OINV improves mood. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm A: Patients receive aprepitant orally once daily for 7 days in the absence of unacceptable toxicity or persistent grade 4 nausea and vomiting. Arm B: Patients receive ondansetron hydrochloride orally 3 times daily for 7 days in the absence of unacceptable toxicity or persistent grade 4 nausea and vomiting. Patients complete the following questionnaires: Functional Assessment of Cancer Therapy-General (FACT-G); Center for Epidemiologic Studies Depression Scale (CES-D); and Brief Pain Index (BPI) at baseline and on day 7. Patients also complete symptom diaries documenting the following: number of episodes (an emetic episode is defined as a simple vomit or retch, or any number of continuous vomits or retches; distinct episodes that are separated by at least 1 minute) of vomiting or retching including the date and time; worst and average degree of nausea (recorded every 2 hours while awake during the first 24 hours after treatment and every 8 hours on days 1-7); and adverse events other than episodes of vomiting and nausea.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Nausea and Vomiting, Solid Tumor
    Keywords
    unspecified adult solid tumor, protocol specific, nausea and vomiting, chronic myelogenous leukemia, chronic eosinophilic leukemia, chronic idiopathic myelofibrosis, chronic neutrophilic leukemia, essential thrombocythemia, polycythemia vera, adult acute lymphoblastic leukemia, adult acute myeloid leukemia, acute undifferentiated leukemia, mast cell leukemia, adult T-cell leukemia/lymphoma, T-cell large granular lymphocyte leukemia, chronic lymphocytic leukemia, hairy cell leukemia, prolymphocytic leukemia, AIDS-related lymphoma, adult Hodgkin lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, cutaneous B-cell non-Hodgkin lymphoma, cutaneous T-cell non-Hodgkin lymphoma, mycosis fungoides/Sezary syndrome, adult grade III lymphomatoid granulomatosis, adult nasal type extranodal NK/T-cell lymphoma, Waldenstrom macroglobulinemia, adult Burkitt lymphoma, adult diffuse large cell lymphoma, adult diffuse mixed cell lymphoma, adult diffuse small cleaved cell lymphoma, adult immunoblastic large cell lymphoma, adult lymphoblastic lymphoma, grade 1 follicular lymphoma, grade 2 follicular lymphoma, grade 3 follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, small lymphocytic lymphoma, intraocular lymphoma, primary central nervous system lymphoma, post-transplant lymphoproliferative disorder, multiple myeloma and other plasma cell neoplasms, myelodysplastic syndromes, atypical chronic myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, chronic myeloproliferative disorders, myelodysplastic/myeloproliferative diseases

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ARM A
    Arm Type
    Experimental
    Arm Title
    ARM B
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    aprepitant
    Other Intervention Name(s)
    EMEND
    Intervention Description
    125 mg orally for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    ondansetron hydrochloride
    Other Intervention Name(s)
    Zofran
    Intervention Description
    24 mg orally for 7 days
    Primary Outcome Measure Information:
    Title
    Control of nausea and vomiting
    Time Frame
    Day 1 and Day 7
    Secondary Outcome Measure Information:
    Title
    Quality of life
    Time Frame
    Day 1 and Day 7
    Title
    Pain control
    Time Frame
    Day 1 and Day 7
    Title
    Mood
    Time Frame
    Day 1 and Day 7
    Title
    Global satisfaction
    Time Frame
    Day 1 and Day 7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: History of malignancy (including hematological malignancies) Has pain requiring opioid analgesics Nausea and vomiting (associated with opioid analgesic use) that is unrelieved by at least one standard antiemetic regimen (including 5HT3 antagonist and dexamethasone combination therapy) Patients who have failed ondansetron hydrochloride for treatment of opioid-induced nausea and vomiting will be excluded from the study PATIENT CHARACTERISTICS: ECOG performance status 0-2 Able to assess severity of nausea and vomiting and document it in the diary Women must not be pregnant or lactating Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception Urine pregnancy test will be given to women of childbearing age No concerns about compliance with medication regimen or medical follow-up (patient must be able to tolerate oral dosing) No severe or chronic illness or other causes of nausea and vomiting, that in judgment of the treating physician, will place patient at risk No severe gastrointestinal obstruction or active peptic ulcer disease Serum ALT and AST < 2 times upper limit of normal (ULN) Serum bilirubin < 2 times ULN Serum alkaline phosphatase < 2 times ULN PRIOR CONCURRENT THERAPY: No surgery within the past 7 days No chemotherapy within the past 7 days No total or lower body radiation therapy within the past 7 days Patient may not be scheduled to undergo total body irradiation or lower body irradiation, chemotherapy, or surgery during study participation Patient must not be taking warfarin
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Barbara A. Murphy, MD
    Organizational Affiliation
    Vanderbilt-Ingram Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer

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