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Emend for Multiple-day Emetogenic Chemotherapy

Primary Purpose

Nausea, Vomiting

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aprepitant, ondansetron, dexamethasone
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nausea focused on measuring nausea, vomiting, multiple days, chemotherapy, serotonin receptor antagonist, corticosteroids, aprepitant, rescue therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with a life expectancy > 3 months
  • Subjects with an ECOG performance score < 3
  • Subjects with access to a telephone for follow-up
  • Subjects able to swallow tablets and capsules

Exclusion Criteria:

  • Subjects who previously received aprepitant as prophylaxis for chemotherapy induced nausea and vomiting.
  • Subjects with an allergy, hypersensitivity, or contraindication to aprepitant, dexamethasone, prochlorperazine or a serotonin receptor antagonist.
  • Subject with uncontrolled diabetes or a concurrent illness/condition requiring chronic systemic steroids or pre-existing gastrointestinal pathology.
  • Subjects with a history of excessive alcohol consumption.
  • Women who are pregnant or lactating.
  • Subjects with nausea at baseline or chronically using other antiemetic agent(s).
  • Subjects currently receiving another investigational agent.

  • Subjects taking a medication that can interact with aprepitant, including the following medications:

    • warfarin
    • oral contraceptives
    • tolbutamide
    • phenytoin
    • midazolam
    • ketoconazole
    • rifampin
    • paroxetine
    • diltiazem
  • Subjects with poor hepatic or renal function defined as AST > 3 x ULN, ALT > 3 x ULN, total bilirubin > 3 x ULN, alkaline phosphatase > 3 x ULN or serum creatinine >2 mg/dl measured within three months before starting chemotherapy.

Subjects with hepatic metastases with AST > 5 x ULN, ALT > 5 x ULN, total bilirubin > 5 x ULN, alkaline phosphatase > 5 x ULN.

Sites / Locations

  • University of Illinois Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm study with Emend

Arm Description

On day 1, the subject will receive a total daily dose of oral dexamethasone 12mg, oral ondansetron 24mg, and oral aprepitant 125mg. On days 2 to THE LAST DAY OF THE MODERATELY-HIGH TO HIGHLY EMETOGENIC CHEMOTHERAPY, subjects will receive a total daily dose of oral dexamethasone 12mg, oral ondansetron 24mg, and oral aprepitant 80mg. All anti-emetics should be give one hour before starting chemotherapy administration. FOR TWO DAYS AFTER RECEIVING CHEMOTHERAPY, the subject will be prescribed oral dexamethasone 4mg every 12 hours and oral aprepitant 80 mg every day.

Outcomes

Primary Outcome Measures

Complete Response (Percentage of Patients)
defined as a no emetic episodes and no use of rescue therapy

Secondary Outcome Measures

Complete Protection
defined as no emesis, no use of rescue medications, and a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)
no Emesis
no Nausea
defined as maximum nausea severity < 5 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)
no Significant Nausea
defined as a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)

Full Information

First Posted
July 3, 2008
Last Updated
August 2, 2021
Sponsor
University of Illinois at Chicago
Collaborators
Merck Sharp & Dohme LLC, Northwestern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00711555
Brief Title
Emend for Multiple-day Emetogenic Chemotherapy
Official Title
An Open Label Phase II Study of Aprepitant for Multi-day Moderately-high to Highly Emetogenic Chemotherapy Regimens
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Merck Sharp & Dohme LLC, Northwestern Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to assess the effect of Emend (aprepitant) on nausea and vomiting associated with chemotherapy. Chemotherapy commonly causes nausea and vomiting and this affects patients' quality of life and attitudes toward treatment. Although nausea and vomiting associated with chemotherapy has been decreasing due to improved therapy, some patients will still experience this side effect. Therefore, new medications are needed to decrease the amount of nausea and vomiting patients have with chemotherapy. Emend (aprepitant) is a new medication used to treat nausea and vomiting with chemotherapy, but it has only been studied in patients receiving only one dose of chemotherapy that makes most people sick. However, there is little experience with this medication in patients receiving multiple days of chemotherapy that causes nausea and vomiting.
Detailed Description
In the studies leading to aprepitant's approval, subjects received only one dose of highly emetogenic chemotherapy. Campos et al studied subjects who received their first course of cisplatin containing chemotherapy that included a cisplatin dose 70mg/m2 and reported that aprepitant in addition to granisetron and dexamethasone increased the number of subjects without acute or delayed emesis (p<0.01). A similar study done by Poli-Bigelli et al indicated that adding aprepitant to a standard antiemetic regimen increased the percentage of subjects without emesis and using rescue therapy during the acute phase (83% to 69%; p < 0.001). Adding aprepitant also increased the percentage of subjects with no emesis or use of rescue medications in the delayed phase (68% vs. 47%, p<0.001). Although these studies demonstrate the benefits of aprepitant for a one day chemotherapy regimen, the benefits of adding aprepitant to current standard antiemetic therapy (dexamethasone plus a serotonin receptor antagonist) in subjects receiving multiple days of moderately-high to highly emetogenic chemotherapy have not been examined within a clinical study. We hypothesize that aprepitant with dexamethasone and a serotonin receptor antagonist from days one to two days after finishing chemotherapy will decrease nausea for subjects receiving chemotherapy regimens that include multiple days of treatment with moderately-high to highly emetogenic chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
nausea, vomiting, multiple days, chemotherapy, serotonin receptor antagonist, corticosteroids, aprepitant, rescue therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm study with Emend
Arm Type
Experimental
Arm Description
On day 1, the subject will receive a total daily dose of oral dexamethasone 12mg, oral ondansetron 24mg, and oral aprepitant 125mg. On days 2 to THE LAST DAY OF THE MODERATELY-HIGH TO HIGHLY EMETOGENIC CHEMOTHERAPY, subjects will receive a total daily dose of oral dexamethasone 12mg, oral ondansetron 24mg, and oral aprepitant 80mg. All anti-emetics should be give one hour before starting chemotherapy administration. FOR TWO DAYS AFTER RECEIVING CHEMOTHERAPY, the subject will be prescribed oral dexamethasone 4mg every 12 hours and oral aprepitant 80 mg every day.
Intervention Type
Drug
Intervention Name(s)
aprepitant, ondansetron, dexamethasone
Intervention Description
On day 1, the subject will receive a total daily dose of oral dexamethasone 12mg, oral ondansetron 24mg, and oral aprepitant 125mg. On days 2 to THE LAST DAY OF THE MODERATELY-HIGH TO HIGHLY EMETOGENIC CHEMOTHERAPY, subjects will receive a total daily dose of oral dexamethasone 12mg, oral ondansetron 24mg, and oral aprepitant 80mg. All anti-emetics should be give one hour before starting chemotherapy administration. FOR TWO DAYS AFTER RECEIVING CHEMOTHERAPY, the subject will be prescribed oral dexamethasone 4mg every 12 hours and oral aprepitant 80 mg every day. FOR RESCUE, the subject will be prescribed prochlorperazine 10 mg oral every 4 hours as needed for nausea and prochlorperazine 10 mg intravenous every 4 hours as needed for vomiting.
Primary Outcome Measure Information:
Title
Complete Response (Percentage of Patients)
Description
defined as a no emetic episodes and no use of rescue therapy
Time Frame
cycle 1, day 1
Secondary Outcome Measure Information:
Title
Complete Protection
Description
defined as no emesis, no use of rescue medications, and a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)
Time Frame
cycle 1, day 1
Title
no Emesis
Time Frame
cycle 1, day 1
Title
no Nausea
Description
defined as maximum nausea severity < 5 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)
Time Frame
cycle 1, day 1
Title
no Significant Nausea
Description
defined as a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)
Time Frame
cycle 1, day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with a life expectancy > 3 months Subjects with an ECOG performance score < 3 Subjects with access to a telephone for follow-up Subjects able to swallow tablets and capsules Exclusion Criteria: Subjects who previously received aprepitant as prophylaxis for chemotherapy induced nausea and vomiting. Subjects with an allergy, hypersensitivity, or contraindication to aprepitant, dexamethasone, prochlorperazine or a serotonin receptor antagonist. Subject with uncontrolled diabetes or a concurrent illness/condition requiring chronic systemic steroids or pre-existing gastrointestinal pathology. Subjects with a history of excessive alcohol consumption. Women who are pregnant or lactating. Subjects with nausea at baseline or chronically using other antiemetic agent(s). Subjects currently receiving another investigational agent. Subjects taking a medication that can interact with aprepitant, including the following medications: warfarin oral contraceptives tolbutamide phenytoin midazolam ketoconazole rifampin paroxetine diltiazem Subjects with poor hepatic or renal function defined as AST > 3 x ULN, ALT > 3 x ULN, total bilirubin > 3 x ULN, alkaline phosphatase > 3 x ULN or serum creatinine >2 mg/dl measured within three months before starting chemotherapy. Subjects with hepatic metastases with AST > 5 x ULN, ALT > 5 x ULN, total bilirubin > 5 x ULN, alkaline phosphatase > 5 x ULN.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy Shord, PharmD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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Emend for Multiple-day Emetogenic Chemotherapy

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