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

This study has been withdrawn prior to enrollment.
(slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00499668
First received: July 10, 2007
Last updated: March 29, 2013
Last verified: March 2013
  Purpose

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 Intervention
Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Nausea and Vomiting
Solid Tumor
Drug: aprepitant
Drug: ondansetron hydrochloride

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Acute Non Lymphoblastic Leukemia Anaplastic Large Cell Lymphoma Anaplastic Plasmacytoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Angioimmunoblastic T-cell Lymphoma B-cell Lymphomas Burkitt Lymphoma Central Nervous System Lymphoma, Primary Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Chronic Myeloproliferative Disorders Chronic Neutrophilic Leukemia Cutaneous T-cell Lymphoma Essential Thrombocythemia Follicular Lymphoma Hairy Cell Leukemia Hodgkin Lymphoma Hypereosinophilic Syndrome Large Granular Lymphocyte Leukemia Leukemia, B-cell, Chronic Leukemia, Myeloid Leukemia, T-cell, Chronic Lymphoblastic Lymphoma Lymphoma AIDSrelated Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphomatoid Granulomatosis Lymphosarcoma Mantle Cell Lymphoma Multiple Myeloma Mycosis Fungoides Myelodysplastic Syndromes Myelodysplastic/myeloproliferative Disease Myelofibrosis Plasmablastic Lymphoma Polycythemia Vera Primary Effusion Lymphoma Sezary Syndrome Systemic Mastocytosis Waldenstrom Macroglobulinemia
U.S. FDA Resources

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Control of nausea and vomiting [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
  • Pain control [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
  • Mood [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
  • Global satisfaction [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2007
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499668

Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Barbara A. Murphy, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

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
Study First Received: July 10, 2007
Last Updated: March 29, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014