NCT01504711

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2016

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

October 20, 2020

Completed
Last Updated

April 8, 2021

Status Verified

September 1, 2020

Enrollment Period

4.6 years

First QC Date

December 22, 2011

Results QC Date

November 1, 2018

Last Update Submit

March 14, 2021

Conditions

Gastrointestinal CancerNausea Post Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    From 0-120 hours after first course of chemotherapy

Secondary Outcomes (3)

  • Percentage of Participants With Control of Both Acute and Delayed Vomiting

    in approximately 28 months

  • Percentage of Participants With Control of Both Acute and Delayed Nausea

    in approximately 28 months

  • Overall Survival

    Time of initiation of treatment until death or censor assessed up to 26 months

Study Arms (1)

Treatment (nausea and vomiting prophylaxis)

EXPERIMENTAL

Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.

Drug: fosaprepitant dimeglumine

Interventions

fosaprepitant dimeglumineDRUG

Given IV

Also known as: EMEND®
Treatment (nausea and vomiting prophylaxis)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

fosaprepitantAprepitant

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Philip A. Philip, M.D., Ph.D., F.R.C.P
Organization
Barbara Ann Karmanos Cancer Institute
philipp@karmanos.org
(313)576-8624

Study Officials

  • Philip A. Philip, M.D., Ph.D., F.R.C.P

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2011

First Posted

January 5, 2012

Study Start

June 1, 2012

Primary Completion

December 29, 2016

Study Completion

September 3, 2020

Last Updated

April 8, 2021

Results First Posted

October 20, 2020

Record last verified: 2020-09

Locations

US(1)