NCT00293384

Brief Summary

RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron and dexamethasone works in preventing nausea and vomiting in patients receiving cyclophosphamide before undergoing an autologous stem cell transplant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2004

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

October 3, 2014

Completed
Last Updated

March 15, 2016

Status Verified

February 1, 2016

Enrollment Period

4.7 years

First QC Date

February 16, 2006

Results QC Date

May 12, 2014

Last Update Submit

February 12, 2016

Conditions

Breast CancerChronic Myeloproliferative DisordersGestational Trophoblastic TumorLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsNausea and VomitingNeuroblastomaOvarian CancerTesticular Germ Cell Tumor

Keywords

nausea and vomitingadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)accelerated phase chronic myelogenous leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionatypical chronic myeloid leukemia, BCR-ABL negativeblastic phase chronic myelogenous leukemiachronic eosinophilic leukemiaprimary myelofibrosischronic myelomonocytic leukemiachronic neutrophilic leukemiachronic phase chronic myelogenous leukemiade novo myelodysplastic syndromesdisseminated neuroblastomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuemyelodysplastic/myeloproliferative neoplasm, unclassifiablenodal marginal zone B-cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomapoor prognosis metastatic gestational trophoblastic tumorpreviously treated myelodysplastic syndromesrecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent adult Burkitt lymphomarecurrent adult Hodgkin lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent neuroblastomarecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorrecurrent small lymphocytic lymphomarecurrent malignant testicular germ cell tumorrefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarefractory multiple myelomarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiasecondary myelodysplastic syndromessplenic marginal zone lymphomastage I multiple myelomastage II multiple myelomastage II ovarian epithelial cancerstage III adult Burkitt lymphomastage III adult Hodgkin lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III chronic lymphocytic leukemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III multiple myelomastage III ovarian epithelial cancerstage III small lymphocytic lymphomastage III malignant testicular germ cell tumorstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV adult Burkitt lymphomastage IV adult Hodgkin lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV breast cancerstage IV chronic lymphocytic leukemiastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV ovarian epithelial cancerstage IV small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (1)

  • Proportion of Participants With Controlled Acute Vomiting

    No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.

    at 0-24 hours

Secondary Outcomes (2)

  • Delayed Vomiting Controlled

    at 25-120 hours

  • Toxicity Grade 3, 4, or 5

    at 0-120 hours

Other Outcomes (1)

  • Overall Nausea Controlled

    at 0-120 hours

Study Arms (1)

Aprepitant, Dexamethasone, Cytoxan & Kytril

EXPERIMENTAL

Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning.

Drug: AprepitantDrug: CyclophosphamideDrug: DexamethasoneDrug: Granisetron hydrochloride

Interventions

AprepitantDRUG

Aprepitant 80mg once daily in the morning on days 2 and 3

Also known as: Emend
Aprepitant, Dexamethasone, Cytoxan & Kytril
CyclophosphamideDRUG

Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes

Also known as: Cytoxan®, Neosar®
Aprepitant, Dexamethasone, Cytoxan & Kytril
DexamethasoneDRUG

Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.

Also known as: Decadron, Diodex, Hexadrol, Maxidex, Dexamethasone Sodium Phosphate, Dexamethasone Acetate
Aprepitant, Dexamethasone, Cytoxan & Kytril
Granisetron hydrochlorideDRUG

Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.

Also known as: KYTRIL®
Aprepitant, Dexamethasone, Cytoxan & Kytril

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Undergoing autologous peripheral blood stem cell transplantation and stem cell mobilization using cyclophosphamide * Candidate (per institutional requirements) for autologous peripheral blood stem cell transplantation * No psychiatric illness or multi-system organ failure * No nausea at baseline PATIENT CHARACTERISTICS: * SWOG performance status 0-2 * Fewer than 5 alcoholic drinks per day within the past year * No current illness requiring chronic systemic steroids or requirement for chronic use of anti-emetics * No gastrointestinal obstruction or active peptic ulcer disease * AST and ALT ≤ 3 times upper limit of normal (ULN) * Bilirubin ≤ 3 times ULN * Alkaline phosphatase ≤ 3 times ULN * Creatinine ≤ 2 mg/dL * No known hypersensitivity to any component of the study regimen * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No unrelenting hiccups PRIOR CONCURRENT THERAPY: * No chronic therapeutic warfarin \> 1 mg dose per day * No other concurrent investigational agents * No concurrent oral contraceptives (except for stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine hydrochloride, or diltiazem hydrochloride * No concurrent illegal drugs

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

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsMyeloproliferative DisordersGestational Trophoblastic DiseaseLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesNauseaVomitingNeuroblastomaOvarian NeoplasmsTesticular Germ Cell TumorCongenital AbnormalitiesLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic-PhaseLymphoma, B-Cell, Marginal ZonePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteBurkitt LymphomaHodgkin DiseaseLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeCarcinoma, Ovarian EpithelialLeukemia, Lymphocytic, Chronic, B-CellTesticular NeoplasmsLeukemia, Hairy Cell

Interventions

AprepitantCyclophosphamideDexamethasoneCalcium Dobesilatedexamethasone 21-phosphatedexamethasone acetateGranisetron

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesTrophoblastic NeoplasmsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypePregnancy Complications, NeoplasticPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellLeukemia, LymphoidEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, T-CellCarcinomaLeukemia, B-CellGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular Diseases

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsAzabicyclo CompoundsAza CompoundsIndazolesPyrazolesAzolesBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

There were no other significant limitations except for the details provided.

Results Point of Contact

Title
Muneer Abidi, M.D.
Organization
Barbara Ann Karmanos Cancer Institute
abidim@karmanos.org
(313) 576-8713

Study Officials

  • Muneer H. Abidi, MD

    Barbara Ann Karmanos Cancer Institute

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 17, 2006

Study Start

October 1, 2004

Primary Completion

June 1, 2009

Study Completion

February 1, 2012

Last Updated

March 15, 2016

Results First Posted

October 3, 2014

Record last verified: 2016-02

Locations

US(1)