An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting
Chemotherapy-Induced Nausea and Vomiting
About this trial
This is an interventional prevention trial for Chemotherapy-Induced Nausea and Vomiting
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.
Sites / Locations
- N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center, Department of Chemotherapy
- Minsk City Clinical Oncology Center
- University Clinical Centre of the Republic of Srpska
- Multiprofile Hospital for Active Treatment, Dobrich, Department of Medical Oncology
- Specialized Hospital for Active Treatment in Oncology, Haskovo, Department of Medical Oncology
- Multiprofile Hospital for Active Treatment "Central Onco Hospital", Plovdiv, Department of Medical Oncology
- Complex Oncology Center, Ruse, Department of Medical Oncology
- Multiprofile Hospital for Active Treatment "Serdika", Sofia, Department of Medical Oncology
- University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Department of Medical Oncology
- Multiprofile Hospital for Active Treatment for Wonen's Health "Nadezhda"
- Hospital for Active Treatment of Oncological Diseases "Dr. Marko Antonov Markov", Varna, Department of Medicinal Oncology and Palliative Care
- Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, Clinic of Medical Oncology
- JSC NeoMedi
- LTD Institute of Clinical Oncology
- LTD Aversi Clinic
- LDT High Technology Medical Center University Clinic
- "Sotiria" Chest Diseases Hospital of Athens
- Thermi Clinic S.A.
- General Hospital of Thessaloniki "G. Papanikolaou", University Department of Pulmonology
- Bioclinic Thessalonikis S.A.
- Koranyi National Institute of TBC and Pulmonology
- Uzsoki Hospital, Department of Radiation Oncology
- University of Debrecen, Medical and Health Science Center
- Petz Aladar County Teaching Hospital, Center for Oncoradiology
- Kaposi Mor Teaching Hospital, Centre for Clinical Oncology
- Borsod-Abauj-Zemplen County Hospital and University Educational Hospital
- Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital
- Medical Center of the University of Pecs
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Oncology Hospital, Department of Conservative Oncology
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Clinic of Oncology and Hematology
- Oncopremium Team SRL, Department of Oncology
- Prof. Dr. Alexandru Trestioreanu Institute of Oncology, Medical Oncology Department II
- Coltea Clinical Hospital, Department of Medical Oncology
- Hifu Terramed Conformal SRL, Department of Medical Oncology
- Ianuli Med Consult SRL, Oncology Department
- "Prof. Dr. Ion Chiricuta" Institute of Oncology, Radiotherapy Department I
- Radiotherapy Center Cluj SRL, Department of Oncology
- Constanta Emergency Clinical County Hospital, Department of Medical Oncology
- Oncology Center "Sf. Nectarie", Department of Medical Oncology
- Suceava Sf. Ioan cel Nou Emergency County Hospital, Department of Medical Oncology
- Oncomed SRL, Department of Medical Oncology
- Oncocenter Clinical Oncology SRL, Department of Medical Oncology
- Arkhangelsk Clinical Oncology Center
- Altay Territorial Oncology Center
- Bryansk Regional Oncology Center
- Chelyabinsk Regional Clinical Oncology Center
- Evimed, LLC
- Sverdlovsk Regional Oncology Center
- Ivanovo Regional Oncology Center
- Kaluga Regional Oncology Center
- Republican Clinical Oncology Center
- Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center
- Moscow City Oncology Hospital #62
- Moscow Clinical Scientific and Practical Center
- N.N. Blokhin Russian Oncology Research Center, Surgery Dept. 2
- N.N. Blokhin Russian Oncology Research Center, Surgery Dept. of Female Reproductive System Tumors
- N.N. Blokhin Russian Oncology Research Center
- Branch #1 of Nizhny Novgorod Regional Oncology Center
- City Clinical Hospital #1
- Novosibirsk Regional Oncology Center
- Clinical Oncology Center, Dept. of Chemotherapy
- Clinical Oncology Center
- Orenburg Regional Clinical Oncology Center
- Pyatigorsk Oncology Center
- Regional Clinical Oncology Center
- Samara Regional Clinical Oncology Center
- City Clinical Oncology Center, Thoracic Oncology Dept.
- City Clinical Oncology Center, Urology Oncology Dept.
- City Clinical Oncology Center
- First I.P. Pavlov State Medical University of St. Petersburg
- St.Petersburg Municipal Clinical Oncology Center
- Tambov Regional Oncology Center
- Tomsk Research Institute of Oncology, General Oncology Dept.
- Tomsk Research Institute of Oncology
- Republican Clinical Oncology Center
- Regional Clinical Oncology Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
I.V. palonosetron infusion plus dexamethasone
I.V. palonosetron bolus plus dexamethasone
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.