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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Nausea and Vomiting, Solid Tumor

Intervention / Treatment
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* Drug: aprepitant
* Drug: ondansetron hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM A<br> | Drug: aprepitant<br>* 125 mg orally for 7 days<br>* Other names: EMEND;|
| Experimental: ARM B<br> | Drug: ondansetron hydrochloride<br>* 24 mg orally for 7 days<br>* Other names: Zofran;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of nausea and vomiting |  | Day 1 and Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | Day 1 and Day 7 | 
| Pain control |  | Day 1 and Day 7 | 
| Mood |  | Day 1 and Day 7 | 
| Global satisfaction |  | Day 1 and Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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