Breast Cancer Clinical Trial

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

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.

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Full Description

PRIMARY OBJECTIVES:

I. To determine if control of nausea at cycle 2 in participants who experienced chemotherapy-induced nausea and vomiting (CINV) at cycle 1 is improved by the addition of either prochlorperazine or olanzapine to the control arm of netupitant, palonosetron and dexamethasone.

SECONDARY OBJECTIVES:

I. To determine if olanzapine is more effective than prochlorperazine in controlling nausea at cycle 2 in participants who experienced CINV at cycle 1 when used in combination with netupitant, palonosetron and dexamethasone.

II. To determine if control of vomiting at cycle 2 in patients who experienced CINV at cycle 1 is improved by the addition of either prochlorperazine or olanzapine to the control arm of netupitant, palonosetron and dexamethasone.

III. To determine if olanzapine is more effective than prochlorperazine in controlling vomiting at cycle 2 in participants who experienced CINV at cycle 1 when used in combination with netupitant, palonosetron and dexamethasone.

TERTIARY OBJECTIVES:

I. To create an empirically-based algorithm predicting nausea from breast cancer chemotherapy regimens that takes into account not only state-of-the-art anti-emetic regimens but also participant factors such as age, race, education, ethnicity, quality of life (QOL), alcohol consumption, susceptibility to nausea, expectancy, anxiety, level of nausea on the day prior to treatment, and prior history of nausea.

II. To compare the effects of the interventions on QOL, as assessed by the Functional Assessment of Cancer Therapy- General (FACT-G), by following the same procedures described under the primary aim and the first secondary aim, using change in the FACT-G scores as the response.

III. To provide preliminary data on the frequency and severity of sleep disturbance, fatigue, anxiety, and dizziness, across treatment conditions.

IV. To provide preliminary data on biological factors (e.g. glutathione [GSH] recycling, genetic markers) that may help identify a subgroup of patients at high risk for development of cancer-related or treatment-related side effects, or response to treatment.

OUTLINE:

PART I: Patients receive 1 cycle of standard of care chemotherapy.

PART II: Patients with a nausea score >= 3 at least once on the diary at cycle 1 chemotherapy are randomized into 1 of 3 groups at cycle 2.

GROUP I: Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride orally (PO) on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy every 8 hours (Q8H) on days 1-4.

GROUP II: Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.

GROUP III: Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.

After completion of study treatment, patients are followed up for 30 days.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1200

Study ID:

NCT03367572

Recruitment Status:

Recruiting

Sponsor:

University of Rochester NCORP Research Base

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There are 18 Locations for this study

See Locations Near You

Hawaii MU NCORP
Honolulu Hawaii, 96813, United States More Info
Kate Bryant-Greenwood
Contact
808-586-2979
[email protected]
Decatur Memorial Hospital
Decatur Illinois, 62526, United States More Info
Site Public Contact
Contact
217-876-4740
[email protected]
Bryan A. Faller
Principal Investigator
Gulf South MU-NCORP
New Orleans Louisiana, 70112, United States More Info
Eileen Mederos, RN
Contact
504-568-2428
[email protected]
Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States More Info
Jenna Russell
Contact
734-712-7229
[email protected]
Cancer Research Consortium of West Michigan
Grand Rapids Michigan, 49503, United States More Info
Connie Szczepanek, RN
Contact
616-391-1230
[email protected]
Health Partners Inc
Minneapolis Minnesota, 55454, United States More Info
Sarah Smith
Contact
952-993-3361
[email protected]
Cancer Research for the Ozarks NCORP
Springfield Missouri, 65804, United States More Info
Kristina Gardner
Contact
417-269-4880
[email protected]
Nevada Cancer Research Foundation NCORP
Las Vegas Nevada, 89106, United States More Info
Karen Sartell
Contact
702-384-0013
[email protected]
University of Rochester NCORP Research Base
Rochester New York, 14642, United States
Southeast Clinical Oncology Research Program
Winston-Salem North Carolina, 27104, United States More Info
Susan Tuttle
Contact
336-418-3535
[email protected]
Columbus NCORP
Columbus Ohio, 43215, United States More Info
Sheree Oxley
Contact
614-488-2745
[email protected]
Dayton Clinical Oncology Program
Dayton Ohio, 45459, United States More Info
Mary Ontko
Contact
937-775-1350
[email protected]
Geisinger Cancer Institute NCORP
Danville Pennsylvania, 17822, United States More Info
Heather Albertson
Contact
570-271-7854
[email protected]
Greenville NCORP
Greenville South Carolina, 29615, United States More Info
Kin Williams
Contact
864-522-2066
[email protected]
Upstate Carolina NCORP
Spartanburg South Carolina, 29303, United States More Info
Kamara Mertz-Rivera
Contact
864-560-6104
[email protected]
Saint Vincent Hospital Cancer Center Green Bay
Green Bay Wisconsin, 54301, United States More Info
Amy Koffarnus
Contact
715-221-6432
[email protected]
Brian L. Burnette
Principal Investigator
Gundersen Health System
La Crosse Wisconsin, 54601, United States More Info
Debbie Kettner-Sieber
Contact
608-775-1195
[email protected]
Aurora NCORP
Milwaukee Wisconsin, 53226, United States More Info
Neha Glandt
Contact
414-778-4345
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1200

Study ID:

NCT03367572

Recruitment Status:

Recruiting

Sponsor:


University of Rochester NCORP Research Base

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