- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00499668
Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer
A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ARM A
|
125 mg orally for 7 days
Other Names:
|
Experimental: ARM B
|
24 mg orally for 7 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Control of nausea and vomiting
Time Frame: Day 1 and Day 7
|
Day 1 and Day 7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life
Time Frame: Day 1 and Day 7
|
Day 1 and Day 7
|
Pain control
Time Frame: Day 1 and Day 7
|
Day 1 and Day 7
|
Mood
Time Frame: Day 1 and Day 7
|
Day 1 and Day 7
|
Global satisfaction
Time Frame: Day 1 and Day 7
|
Day 1 and Day 7
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Barbara A. Murphy, MD, Vanderbilt-Ingram Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified adult solid tumor, protocol specific
- chronic myelomonocytic leukemia
- atypical chronic myeloid leukemia
- myelodysplastic/myeloproliferative disease, unclassifiable
- Waldenstrom macroglobulinemia
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- chronic lymphocytic leukemia
- intraocular lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- adult grade III lymphomatoid granulomatosis
- adult nasal type extranodal NK/T-cell lymphoma
- post-transplant lymphoproliferative disorder
- cutaneous B-cell non-Hodgkin lymphoma
- polycythemia vera
- essential thrombocythemia
- prolymphocytic leukemia
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- mantle cell lymphoma
- chronic idiopathic myelofibrosis
- acute undifferentiated leukemia
- nausea and vomiting
- primary central nervous system lymphoma
- myelodysplastic syndromes
- adult acute myeloid leukemia
- marginal zone lymphoma
- mast cell leukemia
- T-cell large granular lymphocyte leukemia
- small lymphocytic lymphoma
- chronic myelogenous leukemia
- hairy cell leukemia
- adult acute lymphoblastic leukemia
- adult Hodgkin lymphoma
- adult T-cell leukemia/lymphoma
- mycosis fungoides/Sezary syndrome
- AIDS-related lymphoma
- adult diffuse large cell lymphoma
- multiple myeloma and other plasma cell neoplasms
- chronic myeloproliferative disorders
- grade 1 follicular lymphoma
- grade 2 follicular lymphoma
- adult Burkitt lymphoma
- adult diffuse mixed cell lymphoma
- adult diffuse small cleaved cell lymphoma
- adult immunoblastic large cell lymphoma
- adult lymphoblastic lymphoma
- grade 3 follicular lymphoma
- myelodysplastic/myeloproliferative diseases
- cutaneous T-cell non-Hodgkin lymphoma
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphatic Diseases
- Immunoproliferative Disorders
- Bone Marrow Diseases
- Hematologic Diseases
- Signs and Symptoms, Digestive
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Precancerous Conditions
- Lymphoma
- Syndrome
- Myelodysplastic Syndromes
- Disease
- Nausea
- Vomiting
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Preleukemia
- Plasmacytoma
- Lymphoproliferative Disorders
- Myeloproliferative Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Antipruritics
- Neurokinin-1 Receptor Antagonists
- Ondansetron
- Aprepitant
Other Study ID Numbers
- VICC SUPP 0513
- VU-VICC-SUPP-0513
- VU-VICC-IRB-070193
- MERCK-VU-VICC-SUPP-0513
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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