Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy
Condition: Malignant Neoplasm
MeSH terms: Neoplasms; Vomiting
Intervention: Palonosetron Hydrochloride; Ondansetron Hydrochloride; Dexamethasone; Fosaprepitant Dimeglumine; Olanzapine; Placebo
Intervention description: Given IV; Given IV or PO; Given PO; Given IV; Given PO; Given IV
Intervention MeSH terms: Dexamethasone; Ondansetron; Olanzapine; Palonosetron; Fosaprepitant; Aprepitant
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 690.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies how well olanzapine with or without fosaprepitant
      work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving
      chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control
      nausea and vomiting in patients during chemotherapy. Olanzapine is usually given in
      combination with other drugs, including fosaprepitant dimeglumine. It is not yet known if
      olanzapine when given with other drugs, is still effective without using fosaprepitant
      dimeglumine for controlling nausea and vomiting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of malignant disease of any stage; (stage I through stage IV)

          -  No prior history of chemotherapy for any malignancy

          -  Scheduled to receive intravenous HEC (highly emetogenic chemotherapy) (either
             cisplatin-containing regimen or doxorubicin and cyclophosphamide [AC]); cisplatin,
             given on a single day, at a dose of >= 70 mg/m^2, with or without other chemotherapy
             agent(s) OR doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2)

          -  No nausea or vomiting =< 24 hours prior to registration

          -  Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for
             women of childbearing potential only

             * A female of childbearing potential is a sexually mature female who: 1) has not
             undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
             postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in
             the preceding 12 consecutive months)

          -  No known diagnosis of dementia; patients with stable treated brain metastases are
             eligible to participate

          -  No known history of central nervous system (CNS) disease (e.g. seizure disorder)

          -  No treatment with another antipsychotic agent such as olanzapine, risperidone,
             quetiapine, clozapine, phenothiazine or butyrophenone =< 30 days prior to registration

          -  No chronic phenothiazine administration as an antipsychotic agent (patients may
             receive prochlorperazine and other phenothiazines as rescue anti-emetic therapy but
             not within 24 hours prior to registration)

          -  No use of amifostine within 7 days prior to registration

          -  No radiotherapy within 7 days prior to registration or planned for one week after the
             current dose of chemotherapy

          -  No use of quinolone antibiotic therapy within 7 days prior to registration

          -  No chronic alcoholism (as determined by the investigator)

          -  No known hypersensitivity to olanzapine

          -  No known uncontrolled cardiac arrhythmia, no known uncontrolled congestive heart
             failure, or no acute myocardial infarction within the previous six months

          -  No history of uncontrolled diabetes mellitus, i.e., no diabetic ketoacidosis; within 6
             months prior to registration; patients are eligible if they have controlled diabetes
             on diet, oral agents, and/or insulin

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

          -  Patients must be able to read and comprehend English; local translation, including
             verbal translation of patient-reported outcomes (PROs) is not permitted

          -  Serum creatinine =< 2.0 mg/dL =< 120 days prior to registration

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x upper limit
             of normal (ULN) =< 120 days prior to registration