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

NCT ID: NCT01018758

Last Updated: 2009-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-07-31

Brief Summary

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).

Conditions

Chemotherapy-Induced Nausea and Vomiting; Non Hodgkin's Lymphoma

Keywords

Non-Hodgkin's lymphoma; Quality of life; Chemotherapy toxicity; aggressive Non Hodgkin's Lymphomas treated with moderately emetogenic chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

palonosetron

Group Type: EXPERIMENTAL

Palonosetron

Intervention Type: DRUG

Palonosetron will be given as an intravenous bolus at the dose of 250 micrograms over 30 seconds beginning 30 minutes before chemotherapy.

Interventions

Palonosetron

Palonosetron will be given as an intravenous bolus at the dose of 250 micrograms over 30 seconds beginning 30 minutes before chemotherapy.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Studio Linfomi

OTHER

Sponsor Role: lead

Responsible Party

Gruppo Italiano Studio Linfomi

Principal Investigators

Nicola Di Renzo, MD

Role: PRINCIPAL_INVESTIGATOR

Gruppo Italiano Studio Linfomi

Locations

Gruppo Italiano Studio Linfomi

Modena, , Italy

Countries

Italy

Other Identifiers

NHLPal

Identifier Type: -

Identifier Source: org_study_id