Emend for Multiple-day Emetogenic Chemotherapy

NCT00711555 | Completed Phase 2 Results

• 1 other identifier: 2005-0363
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Vomiting

Keywords

nausea; vomiting; multiple days; chemotherapy; serotonin receptor antagonist; corticosteroids; aprepitant; rescue therapy

Outcome Measures

Primary Outcomes (1)

• Complete Response (Percentage of Patients)

  defined as a no emetic episodes and no use of rescue therapy

  cycle 1, day 1

Secondary Outcomes (4)

• Complete Protection

  cycle 1, day 1

• no Emesis

  cycle 1, day 1

• no Nausea

  cycle 1, day 1

• no Significant Nausea

  cycle 1, day 1

Study Arms (1)

Single arm study with Emend

EXPERIMENTAL

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.

Drug: aprepitant, ondansetron, dexamethasone

Interventions

aprepitant, ondansetron, dexamethasone DRUG

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.

Single arm study with Emend

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Merck Sharp & Dohme LLC: collaborator
• Northwestern Memorial Hospital: collaborator

Study Sites (1)

University of Illinois Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Aprepitant; Ondansetron; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Sandra Cuellar
• Organization: University of Illinois

scuell1@uic.edu

312-996-6985

Study Officials

• Stacy Shord, PharmD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 9, 2008
• Study Start: November 1, 2005
• Primary Completion: November 1, 2008
• Study Completion: January 1, 2009
• Last Updated: August 4, 2021
• Results First Posted: August 3, 2009

Record last verified: 2021-08

Locations

US (1)