Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Gastrointestinal Cancer Nausea Post Chemotherapy |
Drug: fosaprepitant dimeglumine |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients |
- Control of vomiting [ Time Frame: From 0-120 hours after first course of chemotherapy ] [ Designated as safety issue: No ]Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration.
- Control of acute and delayed vomiting [ Time Frame: in approximately 28 months ] [ Designated as safety issue: No ]
- Control of acute and delayed nausea [ Time Frame: in approximately 28 months ] [ Designated as safety issue: No ]
- Occurrence of any grade 3, 4 or 5 toxicity probably or definitely attributed to treatment [ Time Frame: in approximately 28 months ] [ Designated as safety issue: Yes ]
- Response rate [ Time Frame: 2 months post initiation of treatment ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Time of initiation of treatment until death or censor up to 2 months post treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 42 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (nausea and vomiting prophylaxis)
Patients receive fosaprepitant dimeglumine IV 30 minutes prior to FOLFIRINOX chemotherapy.
|
Drug: fosaprepitant dimeglumine
Given IV
Other Name: EMEND®
|
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| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- 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
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Clinical Trials Office, MD 800-527-6266 | |
| Principal Investigator: Minsig Choi, MD | |
| Sub-Investigator: Anthony F. Shields, MD, PhD | |
| Sub-Investigator: Philip A. Philip, MD, PhD, FRCP | |
| Principal Investigator: | Minsig Choi, MD | Barbara Ann Karmanos Cancer Institute |
More Information
No publications provided
| Responsible Party: | Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01504711 History of Changes |
| Other Study ID Numbers: | 2011-116, NCI-2011-03735 |
| Study First Received: | December 22, 2011 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Nausea Vomiting Gastrointestinal Neoplasms Signs and Symptoms, Digestive Signs and Symptoms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Aprepitant Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 18, 2013