Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer
Myeloproliferative Disorders, Leukemia, Lymphoma
About this trial
This is an interventional supportive care trial for Myeloproliferative Disorders focused on measuring 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
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
ARM A
ARM B