Clinical trial NCT01504711: Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy
Official title: Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Cancer
Nausea Post Chemotherapy
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.

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 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.

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

Primary outcomes:
measure: Percentage of Participants With Control of Vomiting and Rescue Medication Control
timeFrame: From 0-120 hours after first course of chemotherapy
Secondary outcomes:
measure: Percentage of Participants With Control of Both Acute and Delayed Vomiting
timeFrame: in approximately 28 months
measure: Percentage of Participants With Control of Both Acute and Delayed Nausea
timeFrame: in approximately 28 months
measure: Overall Survival
timeFrame: Time of initiation of treatment until death or censor assessed up to 26 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Philip A. Philip, M.D., Ph.D., F.R.C.P
role: PRINCIPAL_INVESTIGATOR
References: