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 : November 4, 2021
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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 : | 1200 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 : | March 9, 2018 |
| Estimated Primary Completion Date : | December 1, 2022 |
| Estimated Study Completion Date : | May 1, 2023 |
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; 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
Locations
| United States, Hawaii | |
| Hawaii MU NCORP | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Virginia McMahon 808-586-2979 Virginia@cc.hawaii.edu | |
| United States, Illinois | |
| Decatur Memorial Hospital | Recruiting |
| Decatur, Illinois, United States, 62526 | |
| Contact: Site Public Contact 217-876-4740 rhamrick@dmhhs.org | |
| Principal Investigator: Bryan A. Faller | |
| Carle Cancer Center NCORP | Recruiting |
| Urbana, Illinois, United States, 61801 | |
| Contact: Betsy Barnick 217-383-6963 Betsy.Barnick@carle.com | |
| United States, Louisiana | |
| Gulf South MU-NCORP | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Eileen Mederos, RN 504-568-2428 Emede1@lsuhsc.edu | |
| United States, Michigan | |
| Cancer Research Consortium of West Michigan | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Connie Szczepanek, RN 616-391-1230 connie.szczepanek@grcop.org | |
| United States, Minnesota | |
| Health Partners Inc | Recruiting |
| Minneapolis, Minnesota, United States, 55454 | |
| Contact: Michelle C. Janelsins 585-275-5513 michelle_janelsins@umc.rochester.edu | |
| Principal Investigator: Michelle C. Janelsins | |
| United States, Nevada | |
| Nevada Cancer Research Foundation NCORP | Recruiting |
| Las Vegas, Nevada, United States, 89106 | |
| Contact: Karen Sartell 702-384-0013 k.sartell@sncrf.org | |
| United States, New York | |
| University of Rochester NCORP Research Base | Active, not recruiting |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Southeast Clinical Oncology Research Program | Recruiting |
| Winston-Salem, North Carolina, United States, 27104 | |
| Contact: Robin Burgess 336-777-3036 rburgess@southeastclinicaloncology.org | |
| United States, Ohio | |
| Columbus NCORP | Recruiting |
| Columbus, Ohio, United States, 43215 | |
| Contact: Sheree Oxley 614-488-2745 sheree@columbuscoop.org | |
| Dayton Clinical Oncology Program | Recruiting |
| Dayton, Ohio, United States, 45459 | |
| Contact: Mary Ontko 937-775-1350 mary.ontko@daytonncorp.org | |
| United States, Pennsylvania | |
| Geisinger Cancer Institute NCORP | Recruiting |
| Danville, Pennsylvania, United States, 17822 | |
| Contact: Heather Albertson 570-271-7854 halbertson@geisinger.edu | |
| United States, South Carolina | |
| Greenville NCORP | Recruiting |
| Greenville, South Carolina, United States, 29615 | |
| Contact: Kin Williams 864-522-2066 KWilliams8@ghs.org | |
| United States, Wisconsin | |
| Saint Vincent Hospital Cancer Center Green Bay | Recruiting |
| Green Bay, Wisconsin, United States, 54301 | |
| Contact: Amy Koffarnus 715-221-6432 Amy.Koffarnus@hshs.org | |
| Principal Investigator: Brian L. Burnette | |
| Gundersen Health System | Recruiting |
| La Crosse, Wisconsin, United States, 54601 | |
| Contact: Debbie Kettner-Sieber 608-775-1195 dkettne@gundersenhealth.org | |
| Aurora NCORP | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Neha Glandt 414-778-4345 neha.glandt@aurora.org | |
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: | November 4, 2021 |
| Last Verified: | November 2021 |
| 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 |