An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting
Condition: Chemotherapy-Induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Palonosetron; Dexamethasone
Intervention MeSH terms: Dexamethasone; Palonosetron
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 441.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.