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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01504711
First Posted: January 5, 2012
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Philip Philip, Barbara Ann Karmanos Cancer Institute
  Purpose
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.

Condition Intervention
Gastrointestinal Cancer Nausea Post Chemotherapy Drug: fosaprepitant dimeglumine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients

Resource links provided by NLM:


Further study details as provided by Philip Philip, Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Control of vomiting [ 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.


Secondary Outcome Measures:
  • Control of acute and delayed vomiting [ Time Frame: in approximately 28 months ]
  • Control of acute and delayed nausea [ Time Frame: in approximately 28 months ]
  • Occurrence of any grade 3, 4 or 5 toxicity probably or definitely attributed to treatment [ Time Frame: in approximately 28 months ]
  • Response rate [ Time Frame: 2 months post initiation of treatment ]
  • Overall survival [ Time Frame: Time of initiation of treatment until death or censor up to 2 months post treatment ]

Estimated Enrollment: 42
Study Start Date: June 2012
Estimated Study Completion Date: November 1, 2017
Estimated Primary Completion Date: November 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (nausea and vomiting prophylaxis)
Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.
Drug: fosaprepitant dimeglumine
Given IV
Other Name: EMEND®

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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:

I. 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01504711


Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Philip Philip
National Cancer Institute (NCI)
Investigators
Principal Investigator: Philip A. Philip, M.D., Ph.D., F.R.C.P Barbara Ann Karmanos Cancer Institute
  More Information

Responsible Party: Philip Philip, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01504711     History of Changes
Other Study ID Numbers: 2011-116
NCI-2011-03735 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30 CA022453I ( Other Identifier: National Institutes of Health )
First Submitted: December 22, 2011
First Posted: January 5, 2012
Last Update Posted: August 22, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Nausea
Vomiting
Gastrointestinal Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Fosaprepitant
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action