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

Condition(s) targeted: Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases; Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: aprepitant (Drug); ondansetron hydrochloride (Drug)

Phase: N/A

Status: Completed

Sponsored by: Vanderbilt-Ingram Cancer Center

Official(s) and/or principal investigator(s):
Barbara A. Murphy, MD, Study Chair, Affiliation: Vanderbilt-Ingram Cancer Center

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.

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

Study design: Supportive Care, Randomized

Primary outcome: Control of nausea and vomiting

Secondary outcome:

Quality of life

Pain control

Mood

Global satisfaction

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

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

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-6838, United States

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

Starting date: August 2007
Last updated: May 23, 2008