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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Studio Linfomi
• Treatments: Emetics; Palonosetron

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.