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

Chemotherapy-Induced Nausea and Vomiting Clinical Trial

— NHLPal  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018758
• Other study ID #: NHLPal
• Status: Completed
• Phase: Phase 2
• First received: November 23, 2009
• Last updated: November 24, 2009
• Start date: July 2006
• Est. completion date: July 2008

Study information

• Verified date: November 2009
• Source: Gruppo Italiano Studio Linfomi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chemotherapy-Induced Nausea and Vomiting
• Lymphoma
• Lymphoma, Non-Hodgkin
• Nausea
• Non Hodgkin's Lymphoma
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Italy	Gruppo Italiano Studio Linfomi	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Studio Linfomi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication)		0-120 hours	No
Secondary	rate of Complete Response		within the first 24 h after chemotherapy and 24-120 h	No
Secondary	number of emetic episodes		within the first 24 h after chemotherapy and 24-120 h	No
Secondary	presence of nausea graded according to Likert scale		within the first 24 h after chemotherapy and 24-120 h	No
Secondary	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	No
Secondary	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	No
Secondary	toxic effects of Palonosetron		within the first 24 h after chemotherapy and 24-120 h	Yes