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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01504711
Other study ID # 2011-116
Secondary ID NCI-2011-03735P3
Status Completed
Phase N/A
First received
Last updated
Start date June 2012
Est. completion date September 3, 2020

Study information

Verified date September 2020
Source Barbara Ann Karmanos Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 3, 2020
Est. primary completion date December 29, 2016
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design


Intervention

Drug:
fosaprepitant dimeglumine
Given IV

Locations

Country Name City State
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan

Sponsors (2)

Lead Sponsor Collaborator
Philip Philip National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. in approximately 28 months
Secondary 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. in approximately 28 months
Secondary Overall Survival Time of initiation of treatment until death or censor assessed up to 26 months
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