Official Title: “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.

Study Type: Interventional

Study Design: Allocation: Randomized, Primary Purpose: Supportive Care

Study Primary Completion Date: April 2008

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.

Intervention(s) in this Clinical Trial

• Drug: aprepitant
• Drug: ondansetron hydrochloride

Primary Measures

• Control of nausea and vomiting

Secondary Measures

• Quality of life
• Pain control
• Mood
• Global satisfaction

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Overall Clinical Trial Officials and Contacts

Barbara A. Murphy, MD Study Chair Vanderbilt-Ingram Cancer Center  

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00499668

Study ID Number: CDR0000558419

ClinicalTrials.gov Identifier: NCT00499668

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database