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NCT Number: NCT01504711

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

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.

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Key information

Conditions

Gastrointestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Nausea Post Chemotherapy Neoplasms Neoplasms by Site

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fosaprepitant dimeglumine

Drug

Given IV

Other names: EMEND®

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of Participants With Control of Both Acute and Delayed Vomiting

    Time frame: in approximately 28 months

    Achieved if a patient has no episodes of vomiting at both 24 and 120 hours after fosaprepitant dimeglumine administration.

  2. Percentage of Participants With Control of Both Acute and Delayed Nausea

    Time frame: in approximately 28 months

    Achieved if a patient has no episodes of nausea at both 24 and 120 hours after fosaprepitant dimeglumine administration.

  3. Overall Survival

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

Sponsors and collaborators

Lead sponsor

Philip Philip

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2020
First posted
Jan 5, 2012
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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