Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer
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| ClinicalTrials.gov Identifier: NCT03367572 |
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Recruitment Status :
Recruiting
First Posted : December 8, 2017
Last Update Posted : February 9, 2023
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Sponsor:
University of Rochester NCORP Research Base
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Luke Peppone, University of Rochester NCORP Research Base
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Carcinoma | Drug: Dexamethasone Other: Laboratory Biomarker Analysis Drug: Netupitant/Palonosetron Hydrochloride Drug: Olanzapine Other: Placebo Drug: Prochlorperazine Other: Quality-of-Life Assessment | Phase 3 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Supportive Care |
| Official Title: | Treatment of Refractory Nausea |
| Actual Study Start Date : | April 19, 2018 |
| Estimated Primary Completion Date : | June 30, 2025 |
| Estimated Study Completion Date : | June 30, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group I (netupitant/palonosetron hydrochloride, dexamethasone
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride 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 Q8H on days 1-4.
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Drug: Dexamethasone
Given PO
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Netupitant/Palonosetron Hydrochloride Given PO
Other Name: Akynzeo Other: Placebo Given PO
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment |
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Experimental: Group II (net/pal hydro, dexa, prochlorperazine, placebo)
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.
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Drug: Dexamethasone
Given PO
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Netupitant/Palonosetron Hydrochloride Given PO
Other Name: Akynzeo Other: Placebo Given PO
Other Names:
Drug: Prochlorperazine Given PO
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment |
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Experimental: Group III (net/pal hydro, dexa, olanzapine, placebo)
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.
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Drug: Dexamethasone
Given PO
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Netupitant/Palonosetron Hydrochloride Given PO
Other Name: Akynzeo Drug: Olanzapine Given PO
Other Names:
Other: Placebo Given PO
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment |
Primary Outcome Measures :
- Average nausea defined as the average nausea rating across 15 assessment points (comparing prochlorperazine or olanzapine to control arm) [ Time Frame: Up to day 4 ]Will be measured on a 7-point scale anchored by "not at all nauseated" and "extremely nauseated".
Secondary Outcome Measures :
- Average nausea defined as the average nausea rating across 15 assessment points (comparing olanzapine to prochlorperazine) [ Time Frame: Up to day 4 ]Will be measured on a 7-point scale anchored by "not at all nauseated" and "extremely nauseated".
- Presence of any vomiting (yes or no) [ Time Frame: Up to day 4 ]Will assess presence of any vomiting (yes or no).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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. Single-day chemotherapy is defined as only one infusion or injection per cycle. 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367572
Contacts
| Contact: Kari Gilliland | 585.275.1364 | Kari_Gilliland@urmc.rochester.edu |
Locations
Show 18 study locations
Sponsors and Collaborators
University of Rochester NCORP Research Base
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Luke Peppone | University of Rochester NCORP Research Base |
| Responsible Party: | Luke Peppone, Associate Professor of Surgery, Radiation Oncology, and Neuroscience, University of Rochester NCORP Research Base |
| ClinicalTrials.gov Identifier: | NCT03367572 |
| Other Study ID Numbers: |
URCC16070 NCI-2017-00902 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) URCC16070 ( Other Identifier: University of Rochester NCORP Research Base ) URCC-16070 ( Other Identifier: DCP ) R01CA200579 ( U.S. NIH Grant/Contract ) UG1CA189961 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 8, 2017 Key Record Dates |
| Last Update Posted: | February 9, 2023 |
| Last Verified: | February 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Dexamethasone Dexamethasone acetate Olanzapine Palonosetron Prochlorperazine Ichthammol BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators |