Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antiemetics; Aprepitant; BB 1101; Cisplatin; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Emetics; Fosaprepitant; Granisetron; Liposomal doxorubicin; Olanzapine; Ondansetron; Palonosetron

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)