Gastrointestinal CancerNCT01504711

Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy

A study testing fosaprepitant dimeglumine in people with Gastrointestinal Cancer and Nausea Post Chemotherapy, run by Philip Philip at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This clinical trial studies fosaprepitant dimeglumine in preventing nausea and vomiting in patients with gastrointestinal cancer receiving combination chemotherapy. Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Gastrointestinal Cancer, Nausea Post Chemotherapy
What is being tested?: fosaprepitant dimeglumine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Jun 2012to 3 Sep 2020
Phase: Interventional
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient receiving FOLFIRINOX chemotherapy
Southwest Oncology Group (SWOG) Performance status 0 or 1
Ability of patient or guardian to understand and to provide voluntary written informed consent

Who cannot join

Patient with current illness requiring chronic systemic steroids use or requiring chronic use of anti emetics
Patients with gastrointestinal (GI) obstruction or active peptic ulcer disease who cannot take oral medication
Known hypersensitivity to any component of the study regimen
Patients taking any of the following medications: Oral contraceptives (except for the administration of stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine, and Diltiazem
Pregnant or nursing women
Patients using illegal drugs

Trial locations and contacts

1 site in 1 country.

United States1 site

Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients

Read the detailed description

PRIMARY OBJECTIVES:

To evaluate efficacy of the addition of fosaprepitant (fosaprepitant dimeglumine) in controlling acute and delayed vomiting with the standard prophylactic anti-emetic combination of 5-HT3 receptor antagonist and dexamethasone for gastrointestinal cancer patients receiving FOLFIRINOX (5-FU [fluorouracil], oxaliplatin and irinotecan [irinotecan hydrochloride]) chemotherapy.

II. To determine the rate of complete response (no emetic episode and no rescue medication) in the combined acute and delayed phase from 0-120 hours after chemotherapy.

SECONDARY OBJECTIVES:

To determine the incidence of nausea and vomiting in both acute (< 24 hours) and delayed (24- 120 hours) setting in patients receiving FOLFIRINOX chemotherapy.

TERTIARY OBJECTIVES:

Follow overall survival in patients receiving FOLFIRINOX chemotherapy.

OUTLINE:

Patients receive fosaprepitant dimeglumine intravenously (IV) 30 minutes prior to FOLFIRINOX chemotherapy.

After completion of study treatment, patients are followed up for 2 months.

Conditions: Gastrointestinal Cancer, Nausea Post Chemotherapy
Being tested: fosaprepitant dimeglumine
Medical subject headings: Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fosaprepitant dimeglumineDrug
Also called EMEND®
Given IV

Study groups in NCT01504711
Study group	Role	What they receive
Treatment (nausea and vomiting prophylaxis)	Experimental	Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. Receives: Drug: fosaprepitant dimeglumine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Control of Vomiting and Rescue Medication Control
Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration.
Measured: From 0-120 hours after first course of chemotherapy

Secondary outcomes (3)

Percentage of Participants With Control of Both Acute and Delayed Vomiting
Achieved if a patient has no episodes of vomiting at both 24 and 120 hours after fosaprepitant dimeglumine administration.
Measured: in approximately 28 months
Percentage of Participants With Control of Both Acute and Delayed Nausea
Achieved if a patient has no episodes of nausea at both 24 and 120 hours after fosaprepitant dimeglumine administration.
Measured: in approximately 28 months
Overall Survival
Measured: Time of initiation of treatment until death or censor assessed up to 26 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 20123 Sep 2020

First posted5 Jan 2012 (estimated)
Study startJun 2012
Primary completion29 Dec 2016
Study completion3 Sep 2020

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 Gastrointestinal CancerStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01504711
Sponsor's protocol ID: 2011-116
Other IDs: NCI-2011-03735, P30 CA022453I, P30CA022453
Status last verified: Sep 2020
First submitted: 22 Dec 2011
Last updated: 8 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients
ClinicalTrials.gov ID: NCT01504711
Acronym / sponsor ID: 2011-116
Conditions: Gastrointestinal Cancer, Nausea Post Chemotherapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Philip PhilipUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Jun 2012
Primary completion: 29 Dec 2016 (actual)
Study completion: 3 Sep 2020 (actual)
First posted: 5 Jan 2012 (estimated)
Results: Posted 20 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To evaluate efficacy of the addition of fosaprepitant (fosaprepitant dimeglumine) in controlling acute and delayed vomiting with the standard prophylactic anti-emetic combination of 5-HT3 receptor antagonist and dexamethasone for gastrointestinal cancer patients receiving FOLFIRINOX (5-FU [fluorouracil], oxaliplatin and irinotecan [irinotecan hydrochloride]) chemotherapy.

II. To determine the rate of complete response (no emetic episode and no rescue medication) in the combined acute and delayed phase from 0-120 hours after chemotherapy.

SECONDARY OBJECTIVES:

To determine the incidence of nausea and vomiting in both acute (< 24 hours) and delayed (24- 120 hours) setting in patients receiving FOLFIRINOX chemotherapy.

TERTIARY OBJECTIVES:

Follow overall survival in patients receiving FOLFIRINOX chemotherapy.

OUTLINE:

Patients receive fosaprepitant dimeglumine intravenously (IV) 30 minutes prior to FOLFIRINOX chemotherapy.

After completion of study treatment, patients are followed up for 2 months.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (nausea and vomiting prophylaxis)	Experimental	Drug: fosaprepitant dimeglumineReceive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient receiving FOLFIRINOX chemotherapy
Southwest Oncology Group (SWOG) Performance status 0 or 1
Ability of patient or guardian to understand and to provide voluntary written informed consent

Key exclusion criteria (6 listed)

Patient with current illness requiring chronic systemic steroids use or requiring chronic use of anti emetics
Patients with gastrointestinal (GI) obstruction or active peptic ulcer disease who cannot take oral medication
Known hypersensitivity to any component of the study regimen
Patients taking any of the following medications: Oral contraceptives (except for the administration of stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine, and Diltiazem
Pregnant or nursing women

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 dimeglumineAlso: EMEND®Given IV	Drug	Treatment (nausea and vomiting prophylaxis)

Primary outcome

Percentage of Participants With Control of Vomiting and Rescue Medication Control
Time frame: From 0-120 hours after first course of chemotherapy
Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration.

3 secondary outcomes

Percentage of Participants With Control of Both Acute and Delayed Vomiting
Time frame: in approximately 28 months
Percentage of Participants With Control of Both Acute and Delayed Nausea
Time frame: in approximately 28 months
Overall Survival
Time frame: Time of initiation of treatment until death or censor assessed up to 26 months

Results and safety

Results posted to the registry on 20 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (Nausea and Vomiting Prophylaxis)	30	27

Primary outcome: Percentage of Participants With Control of Vomiting and Rescue Medication Control

Time frame: From 0-120 hours after first course of chemotherapy. Number (90% Confidence Interval). Unit: percentage of participants

Measure	Treatment (Nausea and Vomiting Prophylaxis) n = 26
Value	26.9 (15.3 to 42.9)

Population analysed: The analysis set includes patients (n=26) who returned an outcomes diary at 24 or 120 hours post treatment. 1 patient could not be evaluated as they did not return their diary.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse event information includes unexpected and/or serious adverse events from cycles 1 and 2 of treatment. As each cycle last approximately 2 weeks, the adverse event information in this report covers the first month of treatment. The mortality information includes death events while the patients were on treatment or in follow-up (up to 27 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	3 of 27 (11.1%)	12 of 27 (44.4%)	22 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 1/2
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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.

Philip A. Philip, M.D., Ph.D., F.R.C.P principal investigator

Barbara Ann Karmanos Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing fosaprepitant dimeglumine in people with Gastrointestinal Cancer and Nausea Post Chemotherapy, run by Philip Philip 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?

The sponsor lists 3 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 8 Apr 2021. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2020). 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?

Percentage of Participants With Control of Vomiting and Rescue Medication Control (time frame: From 0-120 hours after first course of chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01504711.

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 8 Apr 2021.