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

• Sponsor: Philip Philip (Other)
• Overall Status: Completed
• CT.gov ID: NCT01504711
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 99.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Cancer; Nausea Post Chemotherapy	Drug: fosaprepitant dimeglumine	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. 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.

2. 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:

1. 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:

1. 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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Dec 29, 2016
• Actual Study Completion Date: Sep 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (nausea and vomiting prophylaxis) Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.	Drug: fosaprepitant dimeglumine; Given IV; Other Names: EMEND®

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Control of Vomiting and Rescue Medication Control [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.

Secondary Outcome Measures

1. Percentage of Participants With Control of Both Acute and Delayed Vomiting [in approximately 28 months]

   Achieved if a patient has no episodes of vomiting at both 24 and 120 hours after fosaprepitant dimeglumine administration.

2. Percentage of Participants With Control of Both Acute and Delayed Nausea [in approximately 28 months]

   Achieved if a patient has no episodes of nausea at both 24 and 120 hours after fosaprepitant dimeglumine administration.

3. Overall Survival [Time of initiation of treatment until death or censor assessed up to 26 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201

Sponsors and Collaborators

• Philip Philip
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Philip A. Philip, M.D., Ph.D., F.R.C.P, Barbara Ann Karmanos Cancer Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 17, 2014

More Information

Publications

None provided.

• Responsible Party: Philip Philip, Principal Investigator, Barbara Ann Karmanos Cancer Institute
• ClinicalTrials.gov Identifier: NCT01504711
• Other Study ID Numbers: 2011-116; NCI-2011-03735; P30 CA022453I
• First Posted: Jan 5, 2012
• Last Update Posted: Apr 8, 2021
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Gastrointestinal Neoplasms; Nausea; Vomiting; Fosaprepitant; Aprepitant

Study Results

Participant Flow

Arm/Group Title	Treatment (Nausea and Vomiting Prophylaxis)
Arm/Group Description	Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. fosaprepitant dimeglumine: Given IV
Period Title: Overall Study
STARTED	30
COMPLETED	27
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Treatment (Nausea and Vomiting Prophylaxis)
Arm/Group Description	Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. fosaprepitant dimeglumine: Given IV
Overall Participants	27
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	21 77.8%
>=65 years	6 22.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.0 (9.6)
Sex: Female, Male (Count of Participants)
Female	15 55.6%
Male	12 44.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	1 3.7%
Black or African American	5 18.5%
White	21 77.8%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	27 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Control of Vomiting and Rescue Medication Control
Description	Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration.
Time Frame	From 0-120 hours after first course of chemotherapy

Outcome Measure Data

Analysis Population Description

The analysis set includes patients (n=26) who returned an outcomes diary at 24 or 120 hours post treatment. 1 patient could not be evaluated as they did not return their diary.

Arm/Group Title	Treatment (Nausea and Vomiting Prophylaxis)
Arm/Group Description	Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. fosaprepitant dimeglumine: Given IV
Measure Participants	26
Number (90% Confidence Interval) [percentage of participants]	26.9 99.6%

2. Secondary Outcome

Title	Percentage of Participants With Control of Both Acute and Delayed Vomiting
Description	Achieved if a patient has no episodes of vomiting at both 24 and 120 hours after fosaprepitant dimeglumine administration.
Time Frame	in approximately 28 months

Outcome Measure Data

Analysis Population Description

The analysis set includes patients (n=26) who returned an outcomes diary at 24 or 120 hours post treatment. 1 patient could not be evaluated as they did not return their diary.

Arm/Group Title	Treatment (Nausea and Vomiting Prophylaxis)
Arm/Group Description	Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. fosaprepitant dimeglumine: Given IV
Measure Participants	26
Number (90% Confidence Interval) [percentage of participants]	65.4 242.2%

3. Secondary Outcome

Title	Percentage of Participants With Control of Both Acute and Delayed Nausea
Description	Achieved if a patient has no episodes of nausea at both 24 and 120 hours after fosaprepitant dimeglumine administration.
Time Frame	in approximately 28 months

Outcome Measure Data

Analysis Population Description

The analysis set includes patients (n=25) who returned an outcomes diary at 24 or 120 hours post treatment with nausea information filled out. 2 patients could not be evaluated as they did not return their diary with nausea information filled out.

Arm/Group Title	Treatment (Nausea and Vomiting Prophylaxis)
Arm/Group Description	Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. fosaprepitant dimeglumine: Given IV
Measure Participants	25
Number (90% Confidence Interval) [percentage of participants]	28.0 103.7%

4. Secondary Outcome

Title	Overall Survival
Time Frame	Time of initiation of treatment until death or censor assessed up to 26 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Nausea and Vomiting Prophylaxis)
Arm/Group Description	Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. fosaprepitant dimeglumine: Given IV
Measure Participants	27
Median (90% Confidence Interval) [months]	11.5

Adverse Events

Time Frame	The adverse event information includes unexpected and/or serious adverse events from cycles 1 and 2 of treatment. As each cycle last approximately 2 weeks, the adverse event information in this report covers the first month of treatment. The mortality information includes death events while the patients were on treatment or in follow-up (up to 27 months).
Arm/Group Title	All Participants
Arm/Group Description	All participants
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	22/27 (81.5%)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	3/27 (11.1%)
Gastrointestinal disorders
GI bleed from gastric ulcer	1/27 (3.7%)
Uncontrolled nausea	1/27 (3.7%)
bowel obstruction	1/27 (3.7%)
intractable nausea	1/27 (3.7%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	12/27 (44.4%)
Gastrointestinal disorders
Vomiting	4/27 (14.8%)
General disorders
Hypokalemia	3/27 (11.1%)
Dehydration	3/27 (11.1%)
Anemia	3/27 (11.1%)
Hyponatremia	2/27 (7.4%)
Decreased white blood cell count	2/27 (7.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.