Clinical Trial Details
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NCT02116530 : Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy
PhasePhase 3
AgesMin: 18 Years Max: N/A
- 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
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