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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Barbara Ann Karmanos Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Minsig Choi, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT01504711
First received: December 22, 2011
Last updated: January 28, 2014
Last verified: January 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Control of vomiting [ Time Frame: From 0-120 hours after first course of chemotherapy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Control of acute and delayed nausea [ Time Frame: in approximately 28 months ] [ Designated as safety issue: No ]
  • Occurrence of any grade 3, 4 or 5 toxicity probably or definitely attributed to treatment [ Time Frame: in approximately 28 months ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: 2 months post initiation of treatment ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Time of initiation of treatment until death or censor up to 2 months post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504711

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Clinical Trials Office, MD    800-527-6266      
Principal Investigator: Minsig Choi, MD         
Sub-Investigator: Anthony F. Shields, MD, PhD         
Sub-Investigator: Philip A. Philip, MD, PhD, FRCP         
Sub-Investigator: Hemchandra Mahaseth, M.D.         
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Minsig Choi, MD Barbara Ann Karmanos Cancer Institute
  More Information

No publications provided

Responsible Party: Minsig Choi, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01504711     History of Changes
Other Study ID Numbers: 2011-116, NCI-2011-03735
Study First Received: December 22, 2011
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on November 25, 2014