Working... Menu

Palonosetron Plus Dexamethasone in Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04594)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00687011
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : May 15, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to determine if a single intravenous (IV) dose of palonosetron 0.25 mg plus a single IV dose of dexamethasone 8 mg is effective to prevent nausea and vomiting induced by moderately emetogenic chemotherapy in subjects with cancer.

Condition or disease Intervention/treatment Phase
Neoplasms Nausea Vomiting Drug: Palonosetron and Dexamethasone Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Open-label Clinical Trial to Assess the Efficacy, Tolerability and Safety of a Single IV Dose of Palonosetron 0.25 mg + Dexamethasone IV in the Prevention of Moderately Emetogenic Chemotherapy-induced Nausea and Vomit (CINV).
Actual Study Start Date : October 10, 2006
Actual Primary Completion Date : October 27, 2008
Actual Study Completion Date : October 27, 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Palonosetron-dexamethasone Drug: Palonosetron and Dexamethasone
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent, plus single IV dose of dexamethasone 8 mg administered 15 minutes before chemotherapy (in the event of a shortage of IV dexamethasone, a single oral dose of dexamethasone 20 mg or a single IV dose of methylprednisolone 125 mg could be administered).
Other Name: SCH 734291

Primary Outcome Measures :
  1. Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication. [ Time Frame: During 24 hours after administration of chemotherapy. ]

Secondary Outcome Measures :
  1. Proportion of patients who achieved a CR and of those who achieved complete control; Number of emetic episodes; Time to first emetic episode, to administration and need for rescue therapy; and to treatment failure [ Time Frame: Days 1 to 5 at different time intervals for each secondary outcome. ]
  2. Severity of nausea; Patient global satisfaction; Quality of life questionnaire [ Time Frame: Days 1 to 5 at different time intervals for each secondary outcome. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, >= 18 years of age.
  • Histologically or cytologically confirmed malignant disease.
  • Naive or non-naive to chemotherapy.
  • Karnofsky index >= 70%.
  • Scheduled to receive a single dose of at least one of the following agents administered on Study Day 1: any dose of Dactynomicin, Carboplatin, Epirubicin, Idarubicin, Ifosfamide, Irinotecan, Lomustine; or Methotrexate >250 mg/m^2, or Cyclophosphamide <=1500 mg/m^2, or Mitoxantrone <15 mg/m^2, or Doxorubicin >= 20 mg/m^2, or Citarabin > 1g/m^2, Melphalan > 50 mg/m^2 , oxaliplatin > 75 mg/m^2 administered over 1 to 4 hours. The administration of the major chemotherapeutic agent (which is the most emetogenic agent according to the classification of Hesketh, et al., The Oncologist 1999, 4: 191-196) defined Study Day 1 and administration of this agent should not extend beyond 4 hours.
  • Provided signed written informed consent.
  • Females of childbearing potential must be using reliable contraceptive measures with a negative pregnancy test at the pre-treatment visit.
  • If a patient had a known hepatic, renal or cardiovascular impairment and is scheduled to receive the above mentioned chemotherapeutic agents, he/she could be enrolled in this study at the discretion of the investigator.
  • If a patient had experienced at maximum mild nausea following any previous chemotherapy regimen, he/she could be enrolled in this study at the discretion of the investigator.

Exclusion Criteria:

  • Unable to understand or cooperate with the study procedures.
  • Received any investigational drugs within 30 days before study entry.
  • Received any drug with potential anti-emetic efficacy within 24 hours of the start of treatment or will be scheduled to receive until Study Day 5 including 5-HT3 receptor antagonists, metoclopramide, phenothiazine anti-emetics (including prochlorperazine, thiethylperazine and perphenazine), scopolamine, diphenhydramine, chlorpheniramine maleate, trimethobenzamide, all benzodiazepines except temazepam or triazolam used once nightly for sleep, haloperidol, droperidol, tetrahydrocannabinol, or nabilone, any corticosteroid including dexamethasone, hydrocortisone, methylprednisolone, prednisone (excluding topical or inhaled preparations).
  • Seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity.
  • Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy.
  • Ongoing vomiting from any organic etiology.
  • Experienced nausea (moderate or severe) or vomiting following any previous chemotherapy. At the discretion of the investigator, a patient who experienced at maximum mild nausea following any previous chemotherapy might not be excluded from this study.
  • Scheduled to receive any dose of cisplatin, carmustine, hexametilamine, dacarbazine, Mecloretamine, Streptozotocin, Procarbazine o Cyclophosphamide > 1500 mg/m^2 or any other chemotherapeutic agent with an emetogenicity level 5 according to the classification of NCCN Guidelines v1 2005 during Study Days 2-6.
  • Known contraindication to 5-HT3 receptor antagonists.
  • Scheduled to receive radiotherapy of the upper abdomen or cranium during Study Day 2-6.
  • QTc > 500 msec at baseline.

Study Data/Documents: CSR Synopsis  This link exits the site

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00687011     History of Changes
Other Study ID Numbers: P04594
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Layout table for MeSH terms
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents