Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer

This study has been withdrawn prior to enrollment.
(slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00499668
First received: July 10, 2007
Last updated: March 29, 2013
Last verified: March 2013

July 10, 2007
March 29, 2013
August 2007
January 2008   (final data collection date for primary outcome measure)
Control of nausea and vomiting [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
Control of nausea and vomiting
Complete list of historical versions of study NCT00499668 on ClinicalTrials.gov Archive Site
  • Quality of life [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
  • Pain control [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
  • Mood [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
  • Global satisfaction [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
  • Quality of life
  • Pain control
  • Mood
  • Global satisfaction
Not Provided
Not Provided
 
Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer
A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting

RATIONALE: Antiemetic drugs, such as aprepitant and ondansetron, may help lessen nausea and vomiting caused by opioids. It is not yet known whether aprepitant is more effective than ondansetron in treating nausea and vomiting caused by opioids in patients with cancer.

PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works compared to ondansetron in treating nausea and vomiting caused by opioids in patients with cancer.

OBJECTIVES:

Primary

  • To evaluate the efficacy of aprepitant as monotherapy for opioid-induced nausea and vomiting (OINV) in comparison to ondansetron hydrochloride in patients who have failed at least one prior anti-emetic agent/regimen.

Secondary

  • To determine whether control of OINV improves quality of life.
  • To determine if control in OINV decreases pain.
  • To determine if control in OINV improves mood.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

  • Arm A: Patients receive aprepitant orally once daily for 7 days in the absence of unacceptable toxicity or persistent grade 4 nausea and vomiting.
  • Arm B: Patients receive ondansetron hydrochloride orally 3 times daily for 7 days in the absence of unacceptable toxicity or persistent grade 4 nausea and vomiting.

Patients complete the following questionnaires: Functional Assessment of Cancer Therapy-General (FACT-G); Center for Epidemiologic Studies Depression Scale (CES-D); and Brief Pain Index (BPI) at baseline and on day 7. Patients also complete symptom diaries documenting the following: number of episodes (an emetic episode is defined as a simple vomit or retch, or any number of continuous vomits or retches; distinct episodes that are separated by at least 1 minute) of vomiting or retching including the date and time; worst and average degree of nausea (recorded every 2 hours while awake during the first 24 hours after treatment and every 8 hours on days 1-7); and adverse events other than episodes of vomiting and nausea.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Nausea and Vomiting
  • Solid Tumor
  • Drug: aprepitant
    125 mg orally for 7 days
    Other Name: EMEND
  • Drug: ondansetron hydrochloride
    24 mg orally for 7 days
    Other Name: Zofran
  • Experimental: ARM A
    Intervention: Drug: aprepitant
  • Experimental: ARM B
    Intervention: Drug: ondansetron hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2008
January 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • History of malignancy (including hematological malignancies)
  • Has pain requiring opioid analgesics
  • Nausea and vomiting (associated with opioid analgesic use) that is unrelieved by at least one standard antiemetic regimen (including 5HT3 antagonist and dexamethasone combination therapy)

    • Patients who have failed ondansetron hydrochloride for treatment of opioid-induced nausea and vomiting will be excluded from the study

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Able to assess severity of nausea and vomiting and document it in the diary
  • Women must not be pregnant or lactating
  • Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
  • Urine pregnancy test will be given to women of childbearing age
  • No concerns about compliance with medication regimen or medical follow-up (patient must be able to tolerate oral dosing)
  • No severe or chronic illness or other causes of nausea and vomiting, that in judgment of the treating physician, will place patient at risk
  • No severe gastrointestinal obstruction or active peptic ulcer disease
  • Serum ALT and AST < 2 times upper limit of normal (ULN)
  • Serum bilirubin < 2 times ULN
  • Serum alkaline phosphatase < 2 times ULN

PRIOR CONCURRENT THERAPY:

  • No surgery within the past 7 days
  • No chemotherapy within the past 7 days
  • No total or lower body radiation therapy within the past 7 days
  • Patient may not be scheduled to undergo total body irradiation or lower body irradiation, chemotherapy, or surgery during study participation
  • Patient must not be taking warfarin
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00499668
VICC SUPP 0513, VU-VICC-SUPP-0513, VU-VICC-IRB-070193, MERCK-VU-VICC-SUPP-0513
Yes
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Study Chair: Barbara A. Murphy, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP