N/A N=30 Supportive Care

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

Gastrointestinal Cancer · Nausea Post Chemotherapy

Bottom Line

View on ClinicalTrials.gov: NCT01504711 ↗

Enrolled (actual)

Serious AEs

11.1%

Results posted

Oct 2020

Primary outcome: Primary: Percentage of Participants With Control of Vomiting and Rescue Medication Control — 26.9 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: fosaprepitant dimeglumine (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Philip Philip
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Control of Vomiting and Rescue Medication Control	26.9	—
SECONDARY Percentage of Participants With Control of Both Acute and Delayed Vomiting	65.4	—
SECONDARY Percentage of Participants With Control of Both Acute and Delayed Nausea	28.0	—
SECONDARY Overall Survival	11.5	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01504711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.