NCT02116530|CompletedPhase 3ResultsDMC

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

Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Randomized, Double-Blind, Placebo-Controlled Trial

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

Compare

3 other identifiers

A221301NCI-2014-00446U10CA031946

Study Type

interventional

Target

401

Locations

1 country

Sites

177

Timeline

RegisteredApr 2014

StartedAug 2014

CompletionJun 2017

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

401

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Aug 2014

Typical duration for phase_3

Geographic Reach

1 country

177 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

First Submitted

Initial submission to the registry

April 15, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed

4 months until next milestone

Study Start

First participant enrolled

August 20, 2014

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2015

Completed

2 years until next milestone

Results Posted

Study results publicly available

April 10, 2017

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed

Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

April 15, 2014

Results QC Date

December 7, 2016

Last Update Submit

January 14, 2025

Conditions

Hematopoietic/Lymphoid Cancer Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

Proportion of Patients With no Nausea
No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy.
0 to 120 hours after chemotherapy

Secondary Outcomes (4)

Median Nausea Scores
Baseline and Day 2 to Day 6 after chemotherapy
Proportion of Patients With Complete Response
0 to 120 hours after chemotherapy
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Baseline and day 2 to 6 days after chemotherapy
Frequency of Rescue Medication
Day 2 to Day 6 after chemotherapy

Study Arms (2)

Olanzapine + Chemotherapy + Antiemetic treatment

EXPERIMENTAL

Patients 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)

Drug: OlanzapineDrug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)

Placebo + Chemotherapy + Antiemetic treatment

ACTIVE COMPARATOR

Patients 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

Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)Other: Placebo

Interventions

OlanzapineDRUG

oral

Olanzapine + Chemotherapy + Antiemetic treatment

Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)DRUG

oral or IV

Olanzapine + Chemotherapy + Antiemetic treatmentPlacebo + Chemotherapy + Antiemetic treatment

Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)DRUG

oral or IV

Olanzapine + Chemotherapy + Antiemetic treatmentPlacebo + Chemotherapy + Antiemetic treatment

PlaceboOTHER

oral

Placebo + Chemotherapy + Antiemetic treatment

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

* 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (177)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC