Chemotherapy-Induced Nausea and Vomiting Clinical Trial
— NHLPalOfficial 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
Verified date | November 2009 |
Source | Gruppo Italiano Studio Linfomi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 86 |
Est. completion date | July 2008 |
Est. primary completion date | |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Italy | Gruppo Italiano Studio Linfomi | Modena |
Lead Sponsor | Collaborator |
---|---|
Gruppo Italiano Studio Linfomi |
Italy,
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 |
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