NHLPal: 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

Sponsor

Gruppo Italiano Studio Linfomi (Other)

Overall Status

Completed

CT.gov ID

NCT01018758

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-Induced Nausea and Vomiting Non Hodgkin's Lymphoma	Drug: Palonosetron	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2006

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.