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What is the primary objective of this study?

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.

Who is eligible to participate?

- 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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hematopoietic/Lymphoid Cancer

Nausea and Vomiting

Unspecified Adult Solid Tumor, Protocol Specific

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Olanzapineoral

Drug:Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)oral or IV

Drug:Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)oral or IV

Other:Placebooral

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Olanzapine + Chemotherapy + Antiemetic treatmentPatients will receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs: Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)

Placebo + Chemotherapy + Antiemetic treatmentPatients will receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs: Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus placebo

Study Status

Completed

Start Date: August 2014

Completed Date: November 2015

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Proportion of Patients With no Nausea

Secondary Outcome: Median Nausea Scores

Study sponsors, principal investigator, and references

Principal Investigator: Rudolph M. Navari, MD, PhD, FACP

Lead Sponsor: Alliance for Clinical Trials in Oncology

Collaborator: National Cancer Institute (NCI)

More information:https://clinicaltrials.gov/show/NCT02116530