Emend for Multiple-day Emetogenic Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00711555
Recruitment Status : Completed
First Posted : July 9, 2008
Results First Posted : August 3, 2009
Last Update Posted : August 11, 2009
Merck Sharp & Dohme Corp.
Northwestern Memorial Hospital
Information provided by:
University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Drug: aprepitant, ondansetron, dexamethasone Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Open Label Phase II Study of Aprepitant for Multi-day Moderately-high to Highly Emetogenic Chemotherapy Regimens
Study Start Date : November 2005
Actual Primary Completion Date : November 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: aprepitant, ondansetron, dexamethasone

    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 Measures :
  1. Complete Response [ Time Frame: cycle 1, day 1 ]

Secondary Outcome Measures :
  1. Complete Protection [ Time Frame: cycle 1, day 1 ]
  2. no Emesis [ Time Frame: cycle 1, day 1 ]
  3. no Nausea [ Time Frame: cycle 1, day 1 ]
  4. no Significant Nausea [ Time Frame: cycle 1, day 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00711555

United States, Illinois
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Merck Sharp & Dohme Corp.
Northwestern Memorial Hospital

Responsible Party: Stacy S. Shord, Assistant Professor, University of Illinois at Chicago Identifier: NCT00711555     History of Changes
Obsolete Identifiers: NCT00229489
Other Study ID Numbers: 2005-0363
First Posted: July 9, 2008    Key Record Dates
Results First Posted: August 3, 2009
Last Update Posted: August 11, 2009
Last Verified: August 2009

Keywords provided by University of Illinois at Chicago:
multiple days
serotonin receptor antagonist
quality of life
rescue therapy

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents