- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01504711
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment (nausea and vomiting prophylaxis)
Receive fosaprepitant dimeglumine IV 30 mins.
prior to FOLFIRINOX chemotherapy.
|
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Control of Vomiting and Rescue Medication Control
Time Frame: From 0-120 hours after first course of chemotherapy
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Control of Both Acute and Delayed Vomiting
Time Frame: in approximately 28 months
|
Achieved if a patient has no episodes of vomiting at both 24 and 120 hours after fosaprepitant dimeglumine administration.
|
in approximately 28 months
|
Percentage of Participants With Control of Both Acute and Delayed Nausea
Time Frame: in approximately 28 months
|
Achieved if a patient has no episodes of nausea at both 24 and 120 hours after fosaprepitant dimeglumine administration.
|
in approximately 28 months
|
Overall Survival
Time Frame: Time of initiation of treatment until death or censor assessed up to 26 months
|
Time of initiation of treatment until death or censor assessed up to 26 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip A. Philip, M.D., Ph.D., F.R.C.P, Barbara Ann Karmanos Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Signs and Symptoms, Digestive
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Nausea
- Vomiting
- Gastrointestinal Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Neurokinin-1 Receptor Antagonists
- Aprepitant
- Fosaprepitant
Other Study ID Numbers
- 2011-116
- NCI-2011-03735 (REGISTRY: CTRP (Clinical Trial Reporting Program))
- P30 CA022453I (OTHER: National Institutes of Health)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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