Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Completed 18 and over NCI, Pharmaceutical / Industry VU-VICC-SUPP-0513 VICC-SUPP-0513, VU-VICC-IRB-070193, MERCK-VU-VICC-SUPP-0513, NCT00499668

Objectives

Primary

1. 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

1. To determine whether control of OINV improves quality of life.
2. To determine if control in OINV decreases pain.
3. To determine if control in OINV improves mood.

Entry Criteria

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

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

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

Expected Enrollment

Outcomes

Control of nausea and vomiting

Quality of life
Pain control
Mood
Global satisfaction

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.

Trial Contact Information

Trial Lead Organizations

Vanderbilt-Ingram Cancer Center

Barbara Murphy, MD, Protocol chair		Ph: 615-322-4978; 800-811-8480

Registry Information
Official Title		A Pilot Study of Aprepitant versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting
Trial Start Date		2007-08-22
Trial Completion Date		2008-04-18
Registered in ClinicalTrials.gov		NCT00499668
Date Submitted to PDQ		2007-06-25
Information Last Verified		2008-10-01
NCI Grant/Contract Number		CA68485

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