Emend for Multiple-day Emetogenic Chemotherapy

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Northwestern Memorial Hospital
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00711555
First received: July 3, 2008
Last updated: August 6, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Nausea
Vomiting
Drug: aprepitant, ondansetron, dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Complete Response [ Time Frame: cycle 1, day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete Protection [ Time Frame: cycle 1, day 1 ] [ Designated as safety issue: No ]
  • no Emesis [ Time Frame: cycle 1, day 1 ] [ Designated as safety issue: No ]
  • no Nausea [ Time Frame: cycle 1, day 1 ] [ Designated as safety issue: No ]
  • no Significant Nausea [ Time Frame: cycle 1, day 1 ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: November 2005
Study Completion Date: January 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711555

Locations
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
  More Information

No publications provided

Responsible Party: Stacy S. Shord, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00711555     History of Changes
Obsolete Identifiers: NCT00229489
Other Study ID Numbers: 2005-0363
Study First Received: July 3, 2008
Results First Received: June 11, 2009
Last Updated: August 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Illinois at Chicago:
nausea
vomiting
multiple days
chemotherapy
serotonin receptor antagonist
quality of life
therapy
corticosteroids
aprepitant
rescue therapy

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Ondansetron
Aprepitant
Dexamethasone 21-phosphate
BB 1101
Emetics
Serotonin Antagonists
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on July 22, 2014