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

NCT ID: NCT00499668

Last Updated: 2013-04-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2008-03-31

Brief 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.

Detailed 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.

Conditions

Myeloproliferative Disorders; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Nausea and Vomiting; Solid Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ARM A

Group Type: EXPERIMENTAL

aprepitant

Intervention Type: DRUG

125 mg orally for 7 days

ARM B

Group Type: EXPERIMENTAL

ondansetron hydrochloride

Intervention Type: DRUG

24 mg orally for 7 days

Interventions

aprepitant

125 mg orally for 7 days

Intervention Type: DRUG

ondansetron hydrochloride

24 mg orally for 7 days

Intervention Type: DRUG

Other Intervention Names

EMEND; Zofran

Eligibility Criteria

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Barbara Murphy, MD

Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara A. Murphy, MD

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Other Identifiers

VU-VICC-SUPP-0513

Identifier Type: -

Identifier Source: secondary_id

VU-VICC-IRB-070193

Identifier Type: -

Identifier Source: secondary_id

MERCK-VU-VICC-SUPP-0513

Identifier Type: -

Identifier Source: secondary_id

VICC SUPP 0513

Identifier Type: -

Identifier Source: org_study_id