Clinical trial NCT02557035: An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting
Official title: A Phase 3, Single-dose, Multicenter, Randomized, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of Palonosetron 0.25 mg Administered as a 30-minute IV Infusion Compared to Palonosetron 0.25 mg Administered as a 30-second IV Bolus for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy-Induced Nausea and Vomiting
Lead sponsor: Helsinn Healthcare SA
Sponsor class: INDUSTRY
Collaborators: name: PSI CRO
First posted: 2015-09-22
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of palonosetron 0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered as a 30-second IV bolus (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that infused IV palonosetron 0.25 mg is as effective as (non-inferior to) injected palonosetron IV 0.25 mg to prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single cycle of highly emetogenic chemotherapy


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Histologically or cytologically confirmed solid tumor malignancy.
* Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy will be permitted.
* Scheduled to receive first course of one of the following reference HEC, alone or in combination with other chemotherapeutic agents on Day 1:

  * cisplatin administered as a single IV dose of ≥ 70 mg/m2
  * cyclophosphamide ≥1500 mg/m2
  * carmustine (BCNU) \>250 mg/m2
  * dacarbazine (DTIC)
  * mechloretamine (nitrogen mustard)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 .
* If a patient is female, she shall be of non-childbearing potential or of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test.
* Hematologic and metabolic status adequate for receiving an highly emetogenic regimen based on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance)
* Able to read, understand, follow the study procedure and complete patient diary.

Exclusion Criteria:

* Lactating woman.
* Current use of illicit drugs or current evidence of alcohol abuse.
* Scheduled to receive moderately emetogenic chemotherapy or highly emetogenic chemotherapy from Day 2 to Day 5.
* Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to the start of the reference HEC administration on Day 1 or between Days 1 to 5.
* Any vomiting, retching, or nausea (grade ≥ 1 as defined by National Cancer Institute) within 24 hours prior to the start of the reference HEC administration on Day 1.
* Symptomatic primary or metastatic CNS malignancy.
* Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any illness or medical conditions (other than malignancy) that, in the opinion of the Investigator, may confound the results of the study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting) or pose unwarranted risks in administering the study drugs to the patient.
* Known hypersensitivity or contraindication to 5-HT3 receptor antagonists
* Known contraindication to the IV administration of 50 mL 5% glucose solution.
* Participation in a previous clinical trial involving palonosetron.
* Any investigational drugs (other than those given in this study) taken within 4 weeks prior to Day 1, and/or is scheduled to receive any investigational drug during the present study.
* Systemic corticosteroid therapy at any dose within 72 hours prior to the start of the reference HEC administration on Day 1. However, topical and inhaled corticosteroids are permitted.
* Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.
* Any medication with known or potential antiemetic activity within 24 hours prior to the start of the reference HEC administration on Day 1, including but not limited to 5-HT3 receptor antagonists and NK-1 receptor antagonists
* Concurrent medical condition that would preclude administration of dexamethasone for 4 days such as systemic fungal infection or uncontrolled diabetes.

Primary outcomes:
measure: Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase
timeFrame: 0-24 hours
Secondary outcomes:
measure: Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase
timeFrame: >24-120 hours
measure: Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase
timeFrame: 0-120 hours
measure: Percentage of Patients With no Emetic Episodes in the Acute Phase
timeFrame: 0-24 hours
measure: Percentage of Patients With no Emetic Episodes in the Delayed Phase
timeFrame: >24-120 hours
measure: Percentage of Patients With no Emetic Episodes in the Overall Phase
timeFrame: 0-120 hours
measure: Percentage of Patients With no Rescue Medication in the Acute Phase
timeFrame: 0-24 hours
measure: Percentage of Patients With no Rescue Medication in the Delayed Phase
timeFrame: >24-120 hours
measure: Percentage of Patients With no Rescue Medication in the Overall Phase
timeFrame: 0-120 hours
Other outcomes:
Locations:
city: Lesnoy
country: Belarus
facility: N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center, Department of Chemotherapy
city: Minsk
country: Belarus
facility: Minsk City Clinical Oncology Center
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska
city: Dobrich
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment, Dobrich, Department of Medical Oncology
city: Haskovo
country: Bulgaria
facility: Specialized Hospital for Active Treatment in Oncology, Haskovo, Department of Medical Oncology
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment "Central Onco Hospital", Plovdiv, Department of Medical Oncology
city: Rousse
country: Bulgaria
facility: Complex Oncology Center, Ruse, Department of Medical Oncology
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment "Serdika", Sofia, Department of Medical Oncology
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Department of Medical Oncology
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment for Wonen's Health "Nadezhda"
city: Varna
country: Bulgaria
facility: Hospital for Active Treatment of Oncological Diseases "Dr. Marko Antonov Markov", Varna, Department of Medicinal Oncology and Palliative Care
city: Varna
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, Clinic of Medical Oncology
city: Tbilisi
country: Georgia
facility: JSC NeoMedi
city: Tbilisi
country: Georgia
facility: LTD Institute of Clinical Oncology
city: Tbilisi
country: Georgia
facility: LTD Aversi Clinic
city: Tbilisi
country: Georgia
facility: LDT High Technology Medical Center University Clinic
city: Athens
country: Greece
facility: "Sotiria" Chest Diseases Hospital of Athens
city: Thessaloniki
country: Greece
facility: Thermi Clinic S.A.
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G. Papanikolaou", University Department of Pulmonology
city: Thessaloniki
country: Greece
facility: Bioclinic Thessalonikis S.A.
city: Budapest
country: Hungary
facility: Koranyi National Institute of TBC and Pulmonology
city: Budapest
country: Hungary
facility: Uzsoki Hospital, Department of Radiation Oncology
city: Debrecen
country: Hungary
facility: University of Debrecen, Medical and Health Science Center
city: Gyor
country: Hungary
facility: Petz Aladar County Teaching Hospital, Center for Oncoradiology
city: Kaposvár
country: Hungary
facility: Kaposi Mor Teaching Hospital, Centre for Clinical Oncology
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen County Hospital and University Educational Hospital
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital
city: Pecs
country: Hungary
facility: Medical Center of the University of Pecs
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Oncology Hospital, Department of Conservative Oncology
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Clinic of Oncology and Hematology
city: Baia Mare
country: Romania
facility: Oncopremium Team SRL, Department of Oncology
city: Bucharest
country: Romania
facility: Prof. Dr. Alexandru Trestioreanu Institute of Oncology, Medical Oncology Department II
city: Bucharest
country: Romania
facility: Coltea Clinical Hospital, Department of Medical Oncology
city: Bucharest
country: Romania
facility: Hifu Terramed Conformal SRL, Department of Medical Oncology
city: Bucharest
country: Romania
facility: Ianuli Med Consult SRL, Oncology Department
city: Cluj-Napoca
country: Romania
facility: "Prof. Dr. Ion Chiricuta" Institute of Oncology, Radiotherapy Department I
city: Cluj-Napoca
country: Romania
facility: Radiotherapy Center Cluj SRL, Department of Oncology
city: Constanta
country: Romania
facility: Constanta Emergency Clinical County Hospital, Department of Medical Oncology
city: Craiova
country: Romania
facility: Oncology Center "Sf. Nectarie", Department of Medical Oncology
city: Suceava
country: Romania
facility: Suceava Sf. Ioan cel Nou Emergency County Hospital, Department of Medical Oncology
city: Timisoara
country: Romania
facility: Oncomed SRL, Department of Medical Oncology
city: Timisoara
country: Romania
facility: Oncocenter Clinical Oncology SRL, Department of Medical Oncology
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncology Center
city: Barnaul
country: Russian Federation
facility: Altay Territorial Oncology Center
city: Bryansk
country: Russian Federation
facility: Bryansk Regional Oncology Center
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncology Center
city: Chelyabinsk
country: Russian Federation
facility: Evimed, LLC
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Oncology Center
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Center
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Oncology Center
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Center
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center
city: Moscow
country: Russian Federation
facility: Moscow City Oncology Hospital #62
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific and Practical Center
city: Moscow
country: Russian Federation
facility: N.N. Blokhin Russian Oncology Research Center, Surgery Dept. 2
city: Moscow
country: Russian Federation
facility: N.N. Blokhin Russian Oncology Research Center, Surgery Dept. of Female Reproductive System Tumors
city: Moscow
country: Russian Federation
facility: N.N. Blokhin Russian Oncology Research Center
city: Nizhny Novgorod
country: Russian Federation
facility: Branch #1 of Nizhny Novgorod Regional Oncology Center
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital #1
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Regional Oncology Center
city: Omsk
country: Russian Federation
facility: Clinical Oncology Center, Dept. of Chemotherapy
city: Omsk
country: Russian Federation
facility: Clinical Oncology Center
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Clinical Oncology Center
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk Oncology Center
city: Ryazan
country: Russian Federation
facility: Regional Clinical Oncology Center
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Oncology Center
city: St. Petersburg
country: Russian Federation
facility: City Clinical Oncology Center, Thoracic Oncology Dept.
city: St. Petersburg
country: Russian Federation
facility: City Clinical Oncology Center, Urology Oncology Dept.
city: St. Petersburg
country: Russian Federation
facility: City Clinical Oncology Center
city: St. Petersburg
country: Russian Federation
facility: First I.P. Pavlov State Medical University of St. Petersburg
city: St. Petersburg
country: Russian Federation
facility: St.Petersburg Municipal Clinical Oncology Center
city: Tambov
country: Russian Federation
facility: Tambov Regional Oncology Center
city: Tomsk
country: Russian Federation
facility: Tomsk Research Institute of Oncology, General Oncology Dept.
city: Tomsk
country: Russian Federation
facility: Tomsk Research Institute of Oncology
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Center
city: Veliky Novgorod
country: Russian Federation
facility: Regional Clinical Oncology Center
Study officials:
References: