Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy (NHLPal)

Phase II Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy

This is an open-label, multicenter phase II study in patients with aggressive Non Hodgkin Lymphoma scheduled to receive moderately emetogenic polychemotherapy (according to modified Hesketh classification for antiemetic therapy).

Study Overview

• Status: Completed
• Conditions: Non Hodgkin's Lymphoma; Chemotherapy-Induced Nausea and Vomiting
• Intervention / Treatment: Drug: Palonosetron

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy, 41100
    • Gruppo Italiano Studio Linfomi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, >18 years of age;
• Histologically or cytologically confirmed aggressive NHL (any stage in accordance with the REAL Classification);
• Patients candidates to a initial chemotherapy treatment;
• ECOG performance status of 0-1;
• Scheduled to receive a single intravenous dose of at least one of the moderately emetogenic agents (according to the modified Hesketh classification) on Day 1;
• Written informed consent;
• Female of childbearing potential must be using reliable contraceptive measures;
• Acceptable hepatic and renal functions;
• Willing and able to complete the patient diary.

Exclusion Criteria:

• Highly emetogenic chemotherapy (containing cisplatin, mechlorethamine, streptozotocin, cyclophosphamide >1500 mg/sqm; carmustine; dacarbazine; hexamethylmelamine; procarbazine), or single-agent chemotherapy with drugs having low/minimal emetogenic potential according to the Hesketh classification);
• Diagnosis of Hodgkin's Disease or Leukemia;
• Candidates to High-Dose Chemotherapy or Bone Marrow/Peripheral Blood Stem Cells Transplantation;
• Chemotherapy schedules considering the administration of emetogenic drugs in more than two consecutive days;
• Have received any investigational drugs within 30 days before study entry;
• Have received any drug with potential anti-emetic efficacy (with the exception of specific corticosteroids foreseen in the chemotherapy combination) within 24 hours of treatment initiation);
• Prior treatment with Palonosetron;
• Have a seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity;
• Experienced or ongoing vomiting or nausea from any organic etiology, in the screening phase;
• Clinical evidence of current or impending bowel obstruction, peritonitis, infection, uremia, severe mucositis;
• Clinically relevant electrolyte abnormalities;
• Have a known hypersensitivity to 5HT3 receptor antagonists;
• Radiotherapy within 30 days before chemotherapy administration, or scheduled to receive radiotherapy within two weeks after chemotherapy;
• Female patients who are pregnant or breast feeding;
• Inability to understand or cooperate with the study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: palonosetron	Drug: Palonosetron; Palonosetron will be given as an intravenous bolus at the dose of 250 micrograms over 30 seconds beginning 30 minutes before chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication)	0-120 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
rate of Complete Response	within the first 24 h after chemotherapy and 24-120 h
number of emetic episodes	within the first 24 h after chemotherapy and 24-120 h
presence of nausea graded according to Likert scale	within the first 24 h after chemotherapy and 24-120 h
time to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)	within the first 24 h after chemotherapy and 24-120 h
patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS)	within the first 24 h after chemotherapy and 24-120 h
toxic effects of Palonosetron	within the first 24 h after chemotherapy and 24-120 h

Collaborators and Investigators

• Sponsor: Gruppo Italiano Studio Linfomi
• Investigators: Principal Investigator: Nicola Di Renzo, MD, Gruppo Italiano Studio Linfomi

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: November 23, 2009
• First Submitted That Met QC Criteria: November 24, 2009
• First Posted (Estimate): November 25, 2009

Study Record Updates

• Last Update Posted (Estimate): November 25, 2009
• Last Update Submitted That Met QC Criteria: November 24, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Quality of life; Non-Hodgkin's lymphoma; Chemotherapy toxicity; aggressive Non Hodgkin's Lymphomas treated with moderately emetogenic chemotherapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Signs and Symptoms, Digestive; Aggression; Lymphoma; Nausea; Vomiting; Lymphoma, Non-Hodgkin; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Palonosetron
• Other Study ID Numbers: NHLPal