Clinical trial NCT01363479: An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting
Official title: Single-dose, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Oral Palonosetron 0.50 mg Compared to I.V. Palonosetron 0.25 mg Administered With Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Cisplatin-based 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: Parexel
First posted: 2011-06-01
Enrollment: 743
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-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that oral palonosetron 0.50 mg is as effective as (non-inferior to) 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:

* Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted.
* Diagnosed with a malignant solid tumor and scheduled to receive first course of cytotoxic chemotherapy with cisplatin administered as a single I.V. dose of equal or more than 70 mg/m2 over 1-4 hours on study Day 1, either alone or in combination with other chemotherapeutic agents.
* If scheduled to receive combination regimens, non-cisplatin agents of moderate to high emetogenic potential are allowed and they must be administered following the cisplatin infusion and completed no more than 6 hours after the initiation of cisplatin infusion.
* If scheduled to receive chemotherapy agents of minimal to low emetogenic potential, they are to be given on Day 1 following cisplatin or on any subsequent study day.
* ECOG Performance Status of 0, 1, or 2
* Female patients of either non-childbearing potential or child-bearing potential with a commitment to use contraceptive methods throughout the clinical trial
* Hematologic and metabolic status adequate for receiving a highly emetogenic cisplatin-based regimen based on laboratory criteria (Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance)
* If a patient has a known hepatic or renal impairment, he/she may be enrolled in this study at the discretion of the Investigator.
* If a patient has a known history or predisposition to cardiac conduction interval abnormalities he/she may be enrolled in this study at the discretion of the Investigator.

Exclusion Criteria:

* If female, pregnant or lactating.
* Current use of illicit drugs or current evidence of alcohol abuse.
* Scheduled to receive moderately emetogenic chemotherapy (MEC) or HEC from Day 2 to Day 5 following cisplatin administration.
* Received or is scheduled to receive radiation therapy to the abdomen, or the pelvis within 1 week prior to Day 1 or between Days 1 to 5.
* Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.
* Symptomatic primary or metastatic CNS malignancy.
* Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any uncontrolled 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, CINV) or pose unwarranted risks in administering the study drugs to the patient.
* Known hypersensitivity or contraindication to 5-HT3 receptor antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron) or dexamethasone.
* Participation in a 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 study.
* Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1. However topical and inhaled corticosteroids with a steroid dose of £ 10 mg of prednisone daily or its equivalent 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 Day 1

Primary outcomes:
measure: Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication
timeFrame: 0-24 hours
Secondary outcomes:
measure: Percentage of Patients With no Emesis
timeFrame: 0-24 hours
measure: Percentage of Patients With no Rescue Medication
timeFrame: 0-24 hours
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Genesis Cancer Centre
state: Arkansas
city: Corona
country: United States
facility: Compassionate Cancer Center
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Centre Medical Group
state: California
city: Mission Hills
country: United States
facility: Facey Medical Group
state: California
city: Riverside
country: United States
facility: Compassionate Cancer Care Medical Group
state: California
city: Middletown
country: United States
facility: Signal Point Clinical Research Center, LLC
state: Ohio
city: Bristol
country: United States
facility: Wellmont Medical Associates-Oncology and Hematology
state: Rhode Island
city: Charleston
country: United States
facility: Charleston Hematology Oncology
state: South Carolina
city: Ogden
country: United States
facility: Northern Utah Associates [Hematology/ Oncology]
state: Utah
city: Mar del Plata
country: Argentina
facility: Centro Oncológico Integral (COI)
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Instituto Oncológico de Córdoba (IONC)
city: Córdoba
country: Argentina
facility: Clínica Universitaria Reina Fabiola
city: Quilmes
country: Argentina
facility: Instituto Médico CER [Oncology]
city: Rosario
country: Argentina
facility: Sanatorio Parque
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque
city: Santa Fe
country: Argentina
facility: ISIS Clinica Especializada
city: Gabrovo
country: Bulgaria
facility: MHAT Dr. Tota Venkova
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatement of Oncology Diseases - Sofia District Medical Oncology Department
city: Sofia
country: Bulgaria
facility: UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic
city: Sofia
country: Bulgaria
facility: Specialised Hospital for Active treatment on Oncology
city: Sofia
country: Bulgaria
facility: District Dispensery for Oncology Diseases with in-patient
city: Stara Zagora
country: Bulgaria
facility: Complex Oncology Centre
city: Osijek
country: Croatia
facility: Klinicki bolnicki centar [Oncology]
city: Rijeka
country: Croatia
facility: KBC Rijeka
city: Varazdin
country: Croatia
facility: Opca bolnica Varazdin
city: Zagreb
country: Croatia
facility: KBC Zagreb
city: Zagreb
country: Croatia
facility: Klinicka bolnica [Sestre milosrdnice]
city: Berlin
country: Germany
facility: Klinik und Poliklinik für Onkologie und Hämatologie Universitätsmedizin Charité Mitte
city: Hamburg
country: Germany
facility: OncoResearch Lerchenfeld UG
city: München
country: Germany
facility: Städtisches Klinikum München
city: München
country: Germany
facility: Staedtisches Krankenhaus Muenchen Neuperlach
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Kútvölgyi Klinikai Tömb
city: Budapest
country: Hungary
facility: Fővárosi Önkormányzat Uzsoki utcai Kórház
city: Györ
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház
city: Kecskemet
country: Hungary
facility: Bács-Kiskun Megyei Önkormányzat Kórháza, Szeged
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem [Onkoterápiás Intézet]
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
city: Hyderabad
country: India
facility: Yashoda Super speciality Hospital
state: Andhra Pradesh
city: Pune
country: India
facility: Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation
state: Maharashtra
city: Chennai
country: India
facility: Apollo Speciality Hospital
state: Tamil Nadu
city: Bangalore
country: India
facility: Sri Venkateshwara Hospital [Medical Oncology]
city: Bangalore
country: India
facility: Chinmaya Mission Hospital
city: Vijayawada
country: India
facility: City Cancer Centre [Surgical and Medical Oncology]
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi - ASL Lecce
city: Lecco
country: Italy
facility: Presidio Ospedaliero "Alessandro Manzoni"
city: Potenza
country: Italy
facility: AO Regionale S.Carlo di Potenza
city: Elblag
country: Poland
facility: Szpital Wojewodzki Zespolony
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M.Kopernika
city: Lomza
country: Poland
facility: Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie
city: Warszawa
country: Poland
facility: NZOZ Magodent - Centrum Medczyne Ostrobramska
city: Baia-Mare
country: Romania
facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris"
city: Bucharest
country: Romania
facility: Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta"
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj (Oncologie Medicala)
city: Iasi
country: Romania
facility: Centrul de Oncologie Euroclinic
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu [Oncologie]
city: Timisoara
country: Romania
facility: Oncomed SRL
city: Arkhangelsk
country: Russian Federation
facility: GUZ Arkhangelsk Regional Clinical Oncological Dispensary
city: Krasnoyarsk
country: Russian Federation
facility: GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F.
city: Lipetsk
country: Russian Federation
facility: GUZ Lipetsk Regional Oncology Dispensary [General Oncology]
city: Magnitogorsk
country: Russian Federation
facility: GUZ Regional Oncology Dispensary #2
city: Moscow
country: Russian Federation
facility: RAMN - Russian Cancer Research Center
city: Moscow
country: Russian Federation
facility: Russian Oncology Research Center n.a. N.N. Blokhin RAMN
city: Novosibirsk
country: Russian Federation
facility: MBUZ City Clinical Hospital #1 [Oncology]
city: Obninsk
country: Russian Federation
facility: FGBU "Medical Radiology Scientific Center of Minzdravsotsrazvitiya RF
city: Ryazan
country: Russian Federation
facility: Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio
city: Saint Petersburg
country: Russian Federation
facility: GUZ Leningrad Regional Oncological Dispensary
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg Clinical Oncology Dispesary
city: Chernihiv
country: Ukraine
facility: Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi
city: Dnipropetrovsk
country: Ukraine
facility: Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4
city: Donetsk
country: Ukraine
facility: Komunalno-klinichnyi likuvalno-profilaktychnyi zaklad
city: Kharkiv
country: Ukraine
facility: DU IMR AMNU [vd khemter]
city: Kharkiv
country: Ukraine
facility: Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr
city: Khmelnytskyi
country: Ukraine
facility: Chmelnytskyi Regional Clinical Oncology Centre [Oncology]
city: Uzhgorod
country: Ukraine
facility: Uzhgorod National University
Study officials:
References: