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

Lymphoma Clinical Trial

Official title:

A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00499668
• Other study ID #: VICC SUPP 0513
• Secondary ID: VU-VICC-SUPP-051
• Status: Withdrawn
• Phase: N/A
• First received: July 10, 2007
• Last updated: March 29, 2013
• Start date: August 2007
• Est. completion date: March 2008

Study information

• Verified date: March 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Disease
• Leukemia
• Lymphoma
• Lymphoproliferative Disorder
• Lymphoproliferative Disorders
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myeloproliferative Disorders
• Nausea
• Nausea and Vomiting
• Neoplasms, Plasma Cell
• Plasmacytoma
• Preleukemia
• Solid Tumor
• Vomiting

Intervention

Drug:
• aprepitant
125 mg orally for 7 days
• ondansetron hydrochloride
24 mg orally for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Control of nausea and vomiting		Day 1 and Day 7	No
Secondary	Quality of life		Day 1 and Day 7	No
Secondary	Pain control		Day 1 and Day 7	No
Secondary	Mood		Day 1 and Day 7	No
Secondary	Global satisfaction		Day 1 and Day 7	No