Status:
COMPLETED
Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy
Lead Sponsor:
Philip Philip
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Gastrointestinal Cancer
Nausea Post Chemotherapy
Eligibility:
All Genders
19+ years
Phase:
NA
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 fosaprepi...
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 combinati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01504711
Start Date
June 1 2012
End Date
September 3 2020
Last Update
April 8 2021
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201