Alliance A221602 - "Olanzapine With or Without Fosaprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Phase III Randomized, Double Blind, Placebo-Controlled Trial."
CINV prevention for patients to be treated with HEC or AC, Olanzapine +/- Fosaprepitant, any stage disease.
• Diagnosis of malignant disease. Serum Creatinine ≤2.0 mg/dL
• No prior history of chemotherapy for any malignancy
• Scheduled to receive intravenous HEC (either cisplatin-containing AST or ALT ≤3 x upper limit of normal (ULN) regimen or doxorubicin and cyclophosphamide [AC]). (See Section 3.2.3 for additional details)
• No nausea or vomiting ≤24 hours prior to registration.
• Negative pregnancy test (serum or urine) done ≤7 days prior to registration (See Section 3.2.5).
• No known diagnosis of dementia.(See Section 3.2.6)
• No known history of CNS disease (e.g. seizure disorder).
• No treatment with another antipsychotic agent (see Section 3.2.8)
• No chronic phenothiazine administration as an antipsychotic agent (see Section 3.2.9).
• 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, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months.
• No history of uncontrolled diabetes, i.e., no diabetic ketoacidosis; (See Section 3.2.16)
• Age ≥18 years. • ECOG Performance Status 0, 1 or 2
• Patients must be able to read and comprehend English (See Section 3.2.19)
PLEASE CONTACT NCORP - KC (913/948-5588) WITH ANY STUDY QUESTIONS.