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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
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 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


Arm Intervention/treatment
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.
Drug: Dexamethasone
Given PO
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Netupitant/Palonosetron Hydrochloride
Given PO
Other Name: Akynzeo

Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

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.
Drug: Dexamethasone
Given PO
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Netupitant/Palonosetron Hydrochloride
Given PO
Other Name: Akynzeo

Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Drug: Prochlorperazine
Given PO
Other Names:
  • RP 6140
  • SKF-4657

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

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.
Drug: Dexamethasone
Given PO
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Netupitant/Palonosetron Hydrochloride
Given PO
Other Name: Akynzeo

Drug: Olanzapine
Given PO
Other Names:
  • LY 170053
  • Zydis
  • Zyprexa
  • Zyprexa Zydis

Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  1. 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 :
  1. 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".

  2. Presence of any vomiting (yes or no) [ Time Frame: Up to day 4 ]
    Will assess presence of any vomiting (yes or no).



Information from the National Library of Medicine

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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 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

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
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United States, New York
University of Rochester NCORP Research Base Recruiting
Rochester, New York, United States, 14642
Contact: Joseph Roscoe    585-275-5513    joseph_roscoe@urmc.rochester.edu   
Principal Investigator: Joseph Roscoe         
Sponsors and Collaborators
Gary Morrow
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Joseph Roscoe University of Rochester NCORP Research Base

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Responsible Party: Gary Morrow, Director, URCC NCORP Research Base, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT03367572     History of Changes
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: March 14, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: 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
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors