Gastrointestinal Cancer Clinical Trial
Official title:
Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients
Verified date | September 2020 |
Source | Barbara Ann Karmanos Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Philip Philip | National Cancer Institute (NCI) |
United States,
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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