Breakthrough Nausea and VomitingPhase 1/2NCT01031953
Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy
A Phase 1/2 study testing fosaprepitant dimeglumine, systemic chemotherapy and survey administration in people with Breakthrough Nausea and Vomiting and Unspecified Adult Solid Tumor, Protocol Specific, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. PURPOSE: This clinical trial is studying the side effects of fosaprepitant dimeglumine and to see how well it works in treating patients with nausea and vomiting caused… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breakthrough Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- fosaprepitant dimeglumine, systemic chemotherapy and survey administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Feb 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Scheduled to receive inpatient chemotherapy containing at least moderately emetogenic agents
- May be given for adjuvant, neoadjuvant, curative, or palliative intent
- May be given orally, IV, or by continuous infusion on ≥ 1 day
- Scheduled to receive 5-HT3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, palonosetron, dolasetron mesylate, or dexamethasone with or without a benzodiazepine) on the day of chemotherapy
- Self-report of at least mild nausea (for which the patient feels needs rescuing) or moderate nausea (a score of ≥ 2 on a 4-point Likert scale) OR has had ≥ 1 episode of emesis since receiving chemotherapy
- No history of chronic nausea and/or vomiting (without chemotherapy), anticipatory nausea and/or vomiting, or emesis within 24 hours before chemotherapy
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
- Able to understand English
- Not pregnant or nursing
- Negative pregnancy test
- No clinical evidence of current or impending bowel obstruction (i.e., tumor pressing on the bowel)
- No allergy or intolerance to study drugs
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior chemotherapy allowed
- No aprepitant as prophylaxis or rescue treatment during the current course of chemotherapy (other than as a part of study therapy)
- Not scheduled to receive a dopamine antagonist after chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239-3098
About this study
Official title: Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting
RATIONALE: Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.
PURPOSE: This clinical trial is studying the side effects of fosaprepitant dimeglumine and to see how well it works in treating patients with nausea and vomiting caused by chemotherapy.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the efficacy and safety of fosaprepitant dimeglumine in patients with breakthrough chemotherapy-induced nausea and vomiting (CINV) after failing prophylactic antiemetic therapy.
Secondary
- To evaluate toxicity and serious adverse events associated with this regimen in these patients.
- To evaluate the ability of patients to tolerate oral intake.
- To evaluate the health-related quality of life of patients treated with this regimen.
- To evaluate specific side effects associated with this regimen, including pain sensation and/or soreness at the infusion site, headache, dizziness, and somnolence, in these patients .
- To refine the study design for future phase II and III studies of rescue therapy for breakthrough CINV using various secondary endpoints.
OUTLINE: Patients receive chemotherapy in combination with a pre-defined standard 5-Hydroxytryptamine-3 (5-HT3) antagonist or corticosteroid regimen with or without a benzodiazepine on day 1. If breakthrough nausea or vomiting occurs, patients then receive fosaprepitant dimeglumine IV once per standard administration guidelines. Patients with treatment response may receive additional doses of oral aprepitant once on days 2 and 3. Patients with persistent nausea/vomiting after 2 hours and who desire further treatment may receive standard rescue therapy with prochlorperazine, metoclopramide, or haloperidol with or without additional lorazepam until relief, at the discretion of the provider.
Patients complete a diary at baseline, and then at 2, 12, and 24 hours that includes a Visual Analogue Scale (VAS) for nausea; VAS for sedation; and questions about emesis and retching frequency, headache, dizziness, somnolence, and ability to take food and liquids orally. Patients also complete the Functional Living Index-Emesis Quality of Life survey at baseline and at 24 hours.
- Being tested
- fosaprepitant dimeglumine, systemic chemotherapy, survey administration, quality-of-life assessment
- Keywords
- nausea and vomiting, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fosaprepitant dimeglumineDrug
A 150 mg dose will be given to study patients as rescue therapy after chemotherapy only in the event of breakthrough nausea or vomiting.
systemic chemotherapyDrug
Patients will receive chemotherapy on Day 1 of their scheduled therapeutic regimen in combination with the pre-defined standard 5-Hydroxytryptamine-3 (5HT3) antagonist, corticosteroid regimen, with or without benzodiazepine based on published guidelines3 or as clinically indicated
survey administrationOther
Prior to the first dose of chemotherapy patients will be instructed on how to complete their patient diary
quality-of-life assessmentProcedure or surgery
Patients will also be provided the Functional Living Index - Emesis (FLIE) quality of life survey to be completed at time zero and then after 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Fosaprepitant | Experimental | Not described Receives: Drug: fosaprepitant dimeglumine; Drug: systemic chemotherapy; Other: survey administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale
The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 2 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 2 hours from baseline would be considered in this outcome measure.
Measured: Baseline to 2 hours after study drug administered.
Secondary outcomes (7)
Improvement in Nausea Score From Baseline to 12 Hours
The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 12 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 12 hours from baseline would be considered in this outcome measure.
Measured: Baseline to 12 hours after study drug administered.
Improvement in Nausea Score From 2 Hours to 24 Hours
The outcome measure is the number of participants that self report improvement in a nausea score from 2 hours after receiving fosaprepitant to 24 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant reporting a lower value on the scale at the 12 or 24 hour time point would be considered in this outcome measure.
Measured: 2 hours to 24 hours after study drug administered.
Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours
Participants were asked to report any episodes of vomiting before (baseline) and up to 24 hours after receiving Fosaprepitant. The outcome considers the number of participants reporting any episodes of emesis after receiving Fosaprepitant.
Measured: Baseline to 24 hours after study drug administered.
Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure)
Participants with persistent nausea/vomiting after 2 hours and who desired further treatment, received standard rescue therapy at the discretion of provider with prochlorperazine, metoclopramide or haloperidol with or without additional lorazepam until relief
Measured: 2 hours after administration of Fosaprepitant 150 mg IV
Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required)
The recommended dose Fosaprepitant (MK-0517) is 115 mg administered intravenously 30 minutes before chemotherapy treatment. In this study, a 150 mg dose will be given to study patients as rescue therapy after chemotherapy only in the event of breakthrough nausea or vomiting. Those participants who did not report episodes of emesis or did not require additional rescue medications are measured in this outcome
Measured: up to 24 hours after receiving fosaprepitant
Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant
Participants meeting this outcome self report experiencing drowsiness at any of the study time points (2, 12 or 24 hours after receiving fosaprepitant).
Measured: up to 24 hours after study drug administered.
Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness
Participants who self report pain/soreness at drug infusion site, headache, or dizziness at any of the study time points (2, 12, or 24 hours after receiving fosaprepitant) are measured in this outcome.
Measured: up to 24 hours after study drug administered.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startAug 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Drug contract timelines and inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breakthrough Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Joseph Bubalo, OHSU Knight Cancer Institute
- Investigators
- Joseph Bubalo, PharmD, BCPS, BCOP, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031953
- Sponsor's protocol ID
- CDR0000612580
- Other IDs
- P30CA069533, OHSU-HEM-08053-L
- Status last verified
- May 2017
- First submitted
- 13 Dec 2009
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT01031953
- Acronym / sponsor ID
- CDR0000612580
- Keywords
- nausea and vomiting, unspecified adult solid tumor, protocol specific
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug contract timelines and inadequate enrollment
- Enrolment
- 34 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Posted 30 Jan 2014
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 fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.
PURPOSE: This clinical trial is studying the side effects of fosaprepitant dimeglumine and to see how well it works in treating patients with nausea and vomiting caused by chemotherapy.
Detailed description
OBJECTIVES:
Primary
- To evaluate the efficacy and safety of fosaprepitant dimeglumine in patients with breakthrough chemotherapy-induced nausea and vomiting (CINV) after failing prophylactic antiemetic therapy.
Secondary
- To evaluate toxicity and serious adverse events associated with this regimen in these patients.
- To evaluate the ability of patients to tolerate oral intake.
- To evaluate the health-related quality of life of patients treated with this regimen.
- To evaluate specific side effects associated with this regimen, including pain sensation and/or soreness at the infusion site, headache, dizziness, and somnolence, in these patients .
- To refine the study design for future phase II and III studies of rescue therapy for breakthrough CINV using various secondary endpoints.
OUTLINE: Patients receive chemotherapy in combination with a pre-defined standard 5-Hydroxytryptamine-3 (5-HT3) antagonist or corticosteroid regimen with or without a benzodiazepine on day 1. If breakthrough nausea or vomiting occurs, patients then receive fosaprepitant dimeglumine IV once per standard administration guidelines. Patients with treatment response may receive additional doses of oral aprepitant once on days 2 and 3. Patients with persistent nausea/vomiting after 2 hours and who desire further treatment may receive standard rescue therapy with prochlorperazine, metoclopramide, or haloperidol with or without additional lorazepam until relief, at the discretion of the provider.
Patients complete a diary at baseline, and then at 2, 12, and 24 hours that includes a Visual Analogue Scale (VAS) for nausea; VAS for sedation; and questions about emesis and retching frequency, headache, dizziness, somnolence, and ability to take food and liquids orally. Patients also complete the Functional Living Index-Emesis Quality of Life survey at baseline and at 24 hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fosaprepitant | Experimental | Drug: fosaprepitant dimeglumine, Drug: systemic chemotherapy, Other: survey administration, Procedure: quality-of-life assessment |
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| fosaprepitant dimeglumineA 150 mg dose will be given to study patients as rescue therapy after chemotherapy only in the event of breakthrough nausea or vomiting. | Drug | Fosaprepitant |
| systemic chemotherapyPatients will receive chemotherapy on Day 1 of their scheduled therapeutic regimen in combination with the pre-defined standard 5-Hydroxytryptamine-3 (5HT3) antagonist, corticosteroid regimen, with or without benzodiazepine based on published guidelines3 or as clinically indicated | Drug | Fosaprepitant |
| survey administrationPrior to the first dose of chemotherapy patients will be instructed on how to complete their patient diary | Other | Fosaprepitant |
| quality-of-life assessmentPatients will also be provided the Functional Living Index - Emesis (FLIE) quality of life survey to be completed at time zero and then after 24 hours | Procedure or surgery | Fosaprepitant |
Primary outcome
Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale
Time frame: Baseline to 2 hours after study drug administered.
The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 2 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 2 hours from baseline would be considered in this outcome measure.
7 secondary outcomes
Improvement in Nausea Score From Baseline to 12 Hours
Time frame: Baseline to 12 hours after study drug administered.
Improvement in Nausea Score From 2 Hours to 24 Hours
Time frame: 2 hours to 24 hours after study drug administered.
Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours
Time frame: Baseline to 24 hours after study drug administered.
Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure)
Time frame: 2 hours after administration of Fosaprepitant 150 mg IV
Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required)
Time frame: up to 24 hours after receiving fosaprepitant
Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant
Time frame: up to 24 hours after study drug administered.
Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness
Time frame: up to 24 hours after study drug administered.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joseph Bubalo, PharmD, BCPS, BCOP principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing fosaprepitant dimeglumine, systemic chemotherapy and survey administration in people with Breakthrough Nausea and Vomiting and Unspecified Adult Solid Tumor, Protocol Specific, run by OHSU Knight Cancer Institute at 1 site in United States.
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: stopped early, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale (time frame: Baseline to 2 hours after study drug administered.). 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 9 May 2017.