NCT00499668

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

April 2, 2013

Status Verified

March 1, 2013

Enrollment Period

5 months

First QC Date

July 10, 2007

Last Update Submit

March 29, 2013

Conditions

Myeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisorderMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesNausea and VomitingSolid Tumor

Keywords

unspecified adult solid tumor, protocol specificnausea and vomitingchronic myelogenous leukemiachronic eosinophilic leukemiachronic idiopathic myelofibrosischronic neutrophilic leukemiaessential thrombocythemiapolycythemia veraadult acute lymphoblastic leukemiaadult acute myeloid leukemiaacute undifferentiated leukemiamast cell leukemiaadult T-cell leukemia/lymphomaT-cell large granular lymphocyte leukemiachronic lymphocytic leukemiahairy cell leukemiaprolymphocytic leukemiaAIDS-related lymphomaadult Hodgkin lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomacutaneous B-cell non-Hodgkin lymphomacutaneous T-cell non-Hodgkin lymphomamycosis fungoides/Sezary syndromeadult grade III lymphomatoid granulomatosisadult nasal type extranodal NK/T-cell lymphomaWaldenstrom macroglobulinemiaadult Burkitt lymphomaadult diffuse large cell lymphomaadult diffuse mixed cell lymphomaadult diffuse small cleaved cell lymphomaadult immunoblastic large cell lymphomaadult lymphoblastic lymphomagrade 1 follicular lymphomagrade 2 follicular lymphomagrade 3 follicular lymphomamantle cell lymphomamarginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomasmall lymphocytic lymphomaintraocular lymphomaprimary central nervous system lymphomapost-transplant lymphoproliferative disordermultiple myeloma and other plasma cell neoplasmsmyelodysplastic syndromesatypical chronic myeloid leukemiachronic myelomonocytic leukemiamyelodysplastic/myeloproliferative disease, unclassifiablechronic myeloproliferative disordersmyelodysplastic/myeloproliferative diseases

Outcome Measures

Primary Outcomes (1)

  • Control of nausea and vomiting

    Day 1 and Day 7

Secondary Outcomes (4)

  • Quality of life

    Day 1 and Day 7

  • Pain control

    Day 1 and Day 7

  • Mood

    Day 1 and Day 7

  • Global satisfaction

    Day 1 and Day 7

Study Arms (2)

ARM A

EXPERIMENTAL
Drug: aprepitant

ARM B

EXPERIMENTAL
Drug: ondansetron hydrochloride

Interventions

aprepitantDRUG

125 mg orally for 7 days

Also known as: EMEND
ARM A
ondansetron hydrochlorideDRUG

24 mg orally for 7 days

Also known as: Zofran
ARM B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisordersMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesNauseaVomitingLeukemia, Myelogenous, Chronic, BCR-ABL PositivePdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Neutrophilic, ChronicThrombocythemia, EssentialPolycythemia VeraPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Biphenotypic, AcuteLeukemia, Mast-CellPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Large Granular LymphocyticLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellLeukemia, ProlymphocyticLymphoma, AIDS-RelatedHodgkin DiseaseLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeLymphoma, Extranodal NK-T-CellWaldenstrom MacroglobulinemiaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneIntraocular LymphomaLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeLeukemia, Myelomonocytic, ChronicMyelodysplastic-Myeloproliferative Diseases

Interventions

AprepitantOndansetron

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteLeukemia, LymphoidMastocytosis, SystemicMastocytosisMast Cell Activation DisordersLeukemia, T-CellLeukemia, B-CellLymphoma, B-CellLymphoma, T-CellLymphadenopathyEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye Neoplasms

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolesAzolesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Barbara A. Murphy, MD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 11, 2007

Study Start

August 1, 2007

Primary Completion

January 1, 2008

Study Completion

March 1, 2008

Last Updated

April 2, 2013

Record last verified: 2013-03