Myeloproliferative DisordersNCT00499668
Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer
A study testing aprepitant and ondansetron hydrochloride in people with Myeloproliferative Disorders and Leukemia, run by Vanderbilt-Ingram Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Disorders, Leukemia, Lymphoma
- What is being tested?
- aprepitant and ondansetron hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: 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.
Read the 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.
- Conditions
- Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
- Being tested
- aprepitant, ondansetron hydrochloride
- Keywords
- 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
- Medical subject headings
- Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aprepitantDrug
Also called EMEND
125 mg orally for 7 days
ondansetron hydrochlorideDrug
Also called Zofran
24 mg orally for 7 days
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Experimental | Not described Receives: Drug: aprepitant |
| ARM B | Experimental | Not described Receives: Drug: ondansetron hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of nausea and vomiting
Measured: Day 1 and Day 7
Secondary outcomes (4)
Quality of life
Measured: Day 1 and Day 7
Pain control
Measured: Day 1 and Day 7
Mood
Measured: Day 1 and Day 7
Global satisfaction
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2008
- Study completionMar 2008
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Barbara A. Murphy, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499668
- Sponsor's protocol ID
- VICC SUPP 0513
- Other IDs
- VU-VICC-SUPP-0513, VU-VICC-IRB-070193, MERCK-VU-VICC-SUPP-0513
- Status last verified
- Mar 2013
- First submitted
- 10 Jul 2007
- Last updated
- 2 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT00499668
- Acronym / sponsor ID
- VICC SUPP 0513
- Conditions
- Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A | Experimental | Drug: aprepitant |
| ARM B | Experimental | Drug: ondansetron hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aprepitantAlso: EMEND125 mg orally for 7 days | Drug | ARM A |
| ondansetron hydrochlorideAlso: Zofran24 mg orally for 7 days | Drug | ARM B |
Primary outcome
Control of nausea and vomiting
Time frame: Day 1 and Day 7
4 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara A. Murphy, MD study chair
Vanderbilt-Ingram Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing aprepitant and ondansetron hydrochloride in people with Myeloproliferative Disorders and Leukemia, run by Vanderbilt-Ingram Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of nausea and vomiting (time frame: Day 1 and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2013.