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


N/A
18 Years
N/A
Not Enrolling
Both
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


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.

Inclusion 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

Type of Study:

Interventional

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:

No

Principal Investigator

Barbara A. Murphy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

VICC SUPP 0513

NCT ID:

NCT00499668

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

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