Clinical trial NCT01018758: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Gruppo Italiano Studio Linfomi
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).


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.

Primary outcomes:
measure: overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication)
timeFrame: 0-120 hours
Secondary outcomes:
measure: rate of Complete Response
timeFrame: within the first 24 h after chemotherapy and 24-120 h
measure: number of emetic episodes
timeFrame: within the first 24 h after chemotherapy and 24-120 h
measure: presence of nausea graded according to Likert scale
timeFrame: within the first 24 h after chemotherapy and 24-120 h
measure: time to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)
timeFrame: within the first 24 h after chemotherapy and 24-120 h
measure: patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS)
timeFrame: within the first 24 h after chemotherapy and 24-120 h
measure: toxic effects of Palonosetron
timeFrame: within the first 24 h after chemotherapy and 24-120 h
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Gruppo Italiano Studio Linfomi
Study officials:
affiliation: Gruppo Italiano Studio Linfomi
name: Nicola Di Renzo, MD
role: PRINCIPAL_INVESTIGATOR
References: