Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

unspecified adult solid tumor, protocol specificnausea and vomitingchronic myelogenous leukemiachronic eosinophilic leukemiachronic idiopathic myelofibrosischronic neutrophilic leukemiaessential thrombocythemiapolycythemia veraadult acute lymphoblastic leukemiaadult acute myeloid leukemiaacute undifferentiated leukemiamast cell leukemiaadult T-cell leukemia/lymphomaT-cell large granular lymphocyte leukemiachronic lymphocytic leukemiahairy cell leukemiaprolymphocytic leukemiaAIDS-related lymphomaadult Hodgkin lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomacutaneous B-cell non-Hodgkin lymphomacutaneous T-cell non-Hodgkin lymphomamycosis fungoides/Sezary syndrome

Outcome Measures

Primary Outcomes (1)

Control of nausea and vomiting
Day 1 and Day 7

Secondary Outcomes (4)

Quality of life
Day 1 and Day 7
Pain control
Day 1 and Day 7
Mood
Day 1 and Day 7

Study Arms (2)

ARM A

EXPERIMENTAL

Drug: aprepitant

ARM B

EXPERIMENTAL

Drug: ondansetron hydrochloride

Interventions

aprepitantDrug

125 mg orally for 7 days

Also known as: EMEND

ARM A

ondansetron hydrochlorideDrug

24 mg orally for 7 days

Also known as: Zofran

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

Vanderbilt-Ingram Cancer Center
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisordersMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesNauseaVomitingLeukemia, Myelogenous, Chronic, BCR-ABL PositivePdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Neutrophilic, ChronicThrombocythemia, EssentialPolycythemia VeraPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Study Officials

Barbara A. Murphy, MD
Vanderbilt-Ingram Cancer Center
STUDY CHAIR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 11, 2007

Study Start

August 2007

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

ARM A

ARM B

Interventions

Eligibility Criteria

Sponsors & Collaborators

MeSH Terms

Conditions

Study Officials

Enrollment

Study Design

Study Record Dates

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

ARM A

ARM B

Interventions

Eligibility Criteria

Sponsors & Collaborators

MeSH Terms

Conditions

Study Officials

Enrollment

Study Design

Study Record Dates

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Source record