Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer (URCC 16070)

Treatment of Refractory Nausea

Overview

This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may help lessen nausea and vomiting in patients with breast cancer treated with chemotherapy.

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.

Have a diagnosis of breast cancer and be chemotherapy naive; NOTE: prior methotrexate for non-cancerous conditions is allowed
Be scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin; Herceptin (trastuzumab) and other chemotherapy agents will be allowed with any of these regimens
Be scheduled to receive an antiemetic regimen that does not contain Akynzeo; in addition, the antiemetic regimen must conform with American Society of Clinical Oncology (ASCO) Clinical
Practice Guidelines at cycle 1
Be able to read English
Have the ability to give written informed consent
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
NOTE: patients 80 years of age or older must have approval from an oncologist or their designee to participate in this study
NOTE: patients currently receiving warfarin must have approval from an oncologist or their designee to participate in this study
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, or abstinence) for the duration of the study and have a negative pregnancy test within 10 days prior to the initiation of chemotherapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
CYCLE II PORTION ONLY: Only participants with a nausea score >= 3 at least once on the diary assessment from cycle 1 can be randomized for cycle 2
CYCLE II PORTION ONLY: Participants must be scheduled to receive the same chemotherapy regimen as received at cycle 1

Key Exclusion Criteria

A patient will not be eligible for participation in this study if any of the following criteria apply.

Have clinical evidence of current or impending bowel obstruction
Have a known history of central nervous system disease (e.g., brain metastases or a seizure disorder)
Have dementia
Have uncontrolled diabetes mellitus or uncontrolled hyperglycemia
Have severe hepatic impairment, severe renal impairment, or end-stage renal disease as determined by the treating physician
Have had treatment with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period; NOTE: participants could have received prochlorperazine and other phenothiazines as antiemetic therapy on a short term basis (i.e., =< 5 days)
Have a known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 months
Be taking benzodiazepines
Be taking anticholinergic medications
Be receiving quinolone antibiotic therapy
Be taking amifostine (Ethiofos)
Have a known hypersensitivity to olanzapine or to phenothiazines
CYCLE II PORTION ONLY: Must not have received Akynzeo at cycle 1
CYCLE II PORTION ONLY: Must still meet all the exclusion criteria for cycle 1

Learn More

To learn more, visit ClinicalTrials.Gov

Study Type

Phase III

Sponsor(s)

Gary Morrow