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

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

• Lead Sponsor: University of Rochester NCORP Research Base
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Ichthammol; Olanzapine; Palonosetron; Prochlorperazine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 long term treatment (> 5 days within the past 30 days) 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 regularly (> 5 days within the past 30 days); pro re nata (PRN) use (=< 5 days) for the short-term relief of the symptoms of anxiety, anxiety associated with depressive symptoms, or as a rescue medication for breakthrough CINV is allowed

• 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