Clinical trial NCT00499668: Aprepitant or 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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Nausea and Vomiting
Solid Tumor
Keywords: unspecified adult solid tumor, protocol specific
nausea and vomiting
chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis
chronic neutrophilic leukemia
essential thrombocythemia
polycythemia vera
adult acute lymphoblastic leukemia
adult acute myeloid leukemia
acute undifferentiated leukemia
mast cell leukemia
adult T-cell leukemia/lymphoma
T-cell large granular lymphocyte leukemia
chronic lymphocytic leukemia
hairy cell leukemia
prolymphocytic leukemia
AIDS-related lymphoma
adult Hodgkin lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
cutaneous B-cell non-Hodgkin lymphoma
cutaneous T-cell non-Hodgkin lymphoma
mycosis fungoides/Sezary syndrome
adult grade III lymphomatoid granulomatosis
adult nasal type extranodal NK/T-cell lymphoma
Waldenstrom macroglobulinemia
adult Burkitt lymphoma
adult diffuse large cell lymphoma
adult diffuse mixed cell lymphoma
adult diffuse small cleaved cell lymphoma
adult immunoblastic large cell lymphoma
adult lymphoblastic lymphoma
grade 1 follicular lymphoma
grade 2 follicular lymphoma
grade 3 follicular lymphoma
mantle cell lymphoma
marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
small lymphocytic lymphoma
intraocular lymphoma
primary central nervous system lymphoma
post-transplant lymphoproliferative disorder
multiple myeloma and other plasma cell neoplasms
myelodysplastic syndromes
atypical chronic myeloid leukemia
chronic myelomonocytic leukemia
myelodysplastic/myeloproliferative disease, unclassifiable
chronic myeloproliferative disorders
myelodysplastic/myeloproliferative diseases
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Control of nausea and vomiting
timeFrame: Day 1 and Day 7
Secondary outcomes:
measure: Quality of life
timeFrame: Day 1 and Day 7
measure: Pain control
timeFrame: Day 1 and Day 7
measure: Mood
timeFrame: Day 1 and Day 7
measure: Global satisfaction
timeFrame: Day 1 and Day 7
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Barbara A. Murphy, MD
role: STUDY_CHAIR
References: