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 (NHLPal)
This study has been completed.
Sponsor:
Gruppo Italiano Studio Linfomi
Information provided by:
Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier:
NCT01018758
First received: November 23, 2009
Last updated: November 24, 2009
Last verified: November 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chemotherapy-Induced Nausea and Vomiting Non Hodgkin's Lymphoma |
Drug: Palonosetron |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Gruppo Italiano Studio Linfomi:
Primary Outcome Measures:
- overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) [ Time Frame: 0-120 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- rate of Complete Response [ Time Frame: within the first 24 h after chemotherapy and 24-120 h ] [ Designated as safety issue: No ]
- number of emetic episodes [ Time Frame: within the first 24 h after chemotherapy and 24-120 h ] [ Designated as safety issue: No ]
- presence of nausea graded according to Likert scale [ Time Frame: within the first 24 h after chemotherapy and 24-120 h ] [ Designated as safety issue: No ]
- time to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first) [ Time Frame: within the first 24 h after chemotherapy and 24-120 h ] [ Designated as safety issue: No ]
- patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS) [ Time Frame: within the first 24 h after chemotherapy and 24-120 h ] [ Designated as safety issue: No ]
- toxic effects of Palonosetron [ Time Frame: within the first 24 h after chemotherapy and 24-120 h ] [ Designated as safety issue: Yes ]
| Enrollment: | 86 |
| Study Start Date: | July 2006 |
| Study Completion Date: | July 2008 |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Nicola Di Renzo, Gruppo Italiano Studio Linfomi |
| ClinicalTrials.gov Identifier: | NCT01018758 History of Changes |
| Other Study ID Numbers: | NHLPal |
| Study First Received: | November 23, 2009 |
| Last Updated: | November 24, 2009 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Gruppo Italiano Studio Linfomi:
|
Non-Hodgkin's lymphoma Quality of life Chemotherapy toxicity aggressive Non Hodgkin's Lymphomas treated with moderately emetogenic chemotherapy |
Additional relevant MeSH terms:
|
Aggression Lymphoma Lymphoma, Non-Hodgkin Nausea Vomiting Behavioral Symptoms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Signs and Symptoms, Digestive Signs and Symptoms |
Emetics Palonosetron Physiological Effects of Drugs Pharmacologic Actions Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013