Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy
Condition: Hematopoietic/Lymphoid Cancer; Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Nausea; Vomiting
Intervention: Olanzapine; Chemotherapy (cisplatin or cyclophosphamide and doxorubicin); Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant); Placebo
Intervention description: oral; oral or IV; oral or IV; oral
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Doxorubicin; Ondansetron; Olanzapine; Aprepitant; Fosaprepitant; Palonosetron; Granisetron; Antiemetics
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 401.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies antiemetic therapy with olanzapine to see how well
      they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and
      vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy.
      Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron
      hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with
      chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by
      blocking brain receptors that appear to be involved in nausea and vomiting.
    

Eligibility criteria:

        -  Diagnosis of malignant disease

          -  No prior chemotherapy and scheduled to receive HEC (either cisplatin-containing
             regimen or anthracycline + cyclophosphamide [AC])

               -  Cisplatin at a dose of ≥70mg/m^2, with or without other chemotherapy agent(s) OR

               -  Anthracycline (60 mg/m^2) plus cyclophosphamide(600 mg/m^2)

          -  Age ≥18 years

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2

          -  Required Initial Laboratory Values ≤ 120 days prior to registration

               -  Serum Creatinine ≤2.0 mg/dL

               -  Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic oxaloacetic
                  transaminase (SGPT) ≤3 x Upper Limit of Normal (ULN)

               -  Absolute neutrophil count (ANC) ≥1500/mm^3

          -  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 (per clinician discretion)

          -  No severe cognitive compromise

          -  No known history of CNS disease (e.g. brain metastases, seizure disorder)

          -  No treatment with another antipsychotic agent such as risperidone, quetiapine,
             clozapine, phenothiazine or butyrophenone ≤30 days prior to registration or planned
             during protocol therapy

          -  No chronic phenothiazine administration as an antipsychotic agent (patients may
             receive prochlorperazine and other phenothiazines as rescue anti-emetic therapy)

          -  No concurrent use of amifostine

          -  No concurrent abdominal radiotherapy

          -  No concurrent use of quinolone antibiotic therapy

          -  No chronic alcoholism (as determined by the investigator)

          -  No known hypersensitivity to olanzapine

          -  No known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial
             infarction within the previous six months.

          -  No history of uncontrolled diabetes mellitus (e.g. on insulin or an oral hypoglycemic
             agent)