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
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.