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

NCT01018758 | Completed Phase 2

• 1 other identifier: NHLPal
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication)

  0-120 hours

Secondary Outcomes (6)

• 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

Study Arms (1)

palonosetron

EXPERIMENTAL

Drug: Palonosetron

Interventions

Palonosetron DRUG

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

palonosetron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gruppo Italiano Studio Linfomi: lead

Study Sites (1)

Gruppo Italiano Studio Linfomi

Modena, 41100, Italy

Location

MeSH Terms

Conditions

Vomiting; Lymphoma, Non-Hodgkin

Interventions

Palonosetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nicola Di Renzo, MD

  Gruppo Italiano Studio Linfomi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: November 25, 2009
• Study Start: July 1, 2006
• Study Completion: July 1, 2008
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

IT (1)