Clinical trial · Interventional
Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy
Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients
NCT01504711CI-TRIAL-00051156completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Nausea Post Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fosaprepitant dimeglumine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (nausea and vomiting prophylaxis)
- description
- Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.
- interventionNames
- Drug: fosaprepitant dimeglumine
Primary outcomes (1)
- measure
- Percentage of Participants With Control of Vomiting and Rescue Medication Control
- timeFrame
- From 0-120 hours after first course of chemotherapy
- description
- 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 (3)
- measure
- Percentage of Participants With Control of Both Acute and Delayed Vomiting
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.