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A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting

18 Years
Not Enrolling
Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Nausea and Vomiting, Solid Tumor

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Trial Information

A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting



- 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.


- 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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Control of nausea and vomiting

Outcome Time Frame:

Day 1 and Day 7

Safety Issue:


Principal Investigator

Barbara A. Murphy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

March 2008

Related Keywords:

  • Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Nausea and Vomiting
  • Solid Tumor
  • 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
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Nausea
  • Vomiting