Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer
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| ClinicalTrials.gov Identifier: NCT00499668 |
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Recruitment Status :
Withdrawn
(slow accrual)
First Posted : July 11, 2007
Last Update Posted : April 2, 2013
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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.
| 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 |
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 |
| 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 |
- Control of nausea and vomiting [ Time Frame: Day 1 and Day 7 ]
- Quality of life [ Time Frame: Day 1 and Day 7 ]
- Pain control [ Time Frame: Day 1 and Day 7 ]
- Mood [ Time Frame: Day 1 and Day 7 ]
- 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 |
DISEASE CHARACTERISTICS:
- History of malignancy (including hematological malignancies)
- Has pain requiring opioid analgesics
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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
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
| 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 |
| 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 |
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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 |
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Lymphoma Leukemia Multiple Myeloma Neoplasms, Plasma Cell Preleukemia Plasmacytoma Myelodysplastic Syndromes Lymphoproliferative Disorders Myeloproliferative Disorders Disease Syndrome Nausea Vomiting 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 Ondansetron |