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

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ClinicalTrials.gov Identifier: NCT00499668
Recruitment Status : Withdrawn (slow accrual)
First Posted : July 11, 2007
Last Update Posted : April 2, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

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.


Condition or disease Intervention/treatment Phase
Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Nausea and Vomiting Solid Tumor Drug: aprepitant Drug: ondansetron hydrochloride Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting
Study Start Date : August 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes Multiple Myeloma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Lymphosarcoma Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Myelofibrosis Chronic Myeloproliferative Disorders Polycythemia Vera Essential Thrombocythemia B-cell Lymphoma Diffuse Large B-Cell Lymphoma Acute Lymphoblastic Leukemia Burkitt Lymphoma Cutaneous T-cell Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma Waldenstrom Macroglobulinemia Hodgkin Lymphoma Hairy Cell Leukemia Primary Central Nervous System Lymphoma Extranodal Nasal NK/T Cell Lymphoma Follicular Lymphoma Lymphoma, Large-cell Anaplastic Large Cell Lymphoma Aggressive NK Cell Leukemia Mycosis Fungoides Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Sezary Syndrome Lymphoma AIDS Related Primary Effusion Lymphoma Lymphoblastic Lymphoma Myelodysplastic/myeloproliferative Disease Leukemia, T-cell, Chronic Plasmacytoma Adult T-cell Leukemia/lymphoma Large Granular Lymphocyte Leukemia Lymphomatoid Granulomatosis Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Chronic Neutrophilic Leukemia

Arm Intervention/treatment
Experimental: ARM A Drug: aprepitant
125 mg orally for 7 days
Other Name: EMEND

Experimental: ARM B Drug: ondansetron hydrochloride
24 mg orally for 7 days
Other Name: Zofran




Primary Outcome Measures :
  1. Control of nausea and vomiting [ Time Frame: Day 1 and Day 7 ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Day 1 and Day 7 ]
  2. Pain control [ Time Frame: Day 1 and Day 7 ]
  3. Mood [ Time Frame: Day 1 and Day 7 ]
  4. Global satisfaction [ Time Frame: Day 1 and Day 7 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499668


Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Barbara A. Murphy, MD Vanderbilt-Ingram Cancer Center

Responsible Party: Barbara Murphy, MD, Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00499668     History of Changes
Other Study ID Numbers: VICC SUPP 0513
VU-VICC-SUPP-0513
VU-VICC-IRB-070193
MERCK-VU-VICC-SUPP-0513
First Posted: July 11, 2007    Key Record Dates
Last Update Posted: April 2, 2013
Last Verified: March 2013

Keywords provided by Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center:
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

Additional relevant MeSH terms:
Lymphoma
Disease
Syndrome
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Nausea
Vomiting
Plasmacytoma
Lymphoproliferative Disorders
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Signs and Symptoms, Digestive
Signs and Symptoms