Multicenter, randomized, controlled study to compare palonosetron plus dexamethasone before chemotherapy administration versus the same regimen with dexamethasone continuing on Days 2 and 3 in preventing nausea and vomiting in patients with solid tumors treated with moderately emetogenic chemotherapy - ND

• Conditions: Solid tumours; Level: SOCClassification code 10029104

• Registration Number: EUCTR2006-000644-13-IT
• Lead Sponsor: I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Male or female, 18 years of age; Have histologically or cytologically confirmed solid tumor any stage ; Consecutive enrollment; Patients previously treated or not with chemotherapy; Have an ECOG performance status of 0-2; Be scheduled to receive a single intravenous dose of at least 1 of the moderately emetogenic agents according to the modified Hesketh classification reported in the Appendix 1 on Day 1; Provide written informed consent; If female of childbearing potential must be using reliable contraceptive measures; Acceptable hepatic function 2 times the upper limit of normal for liver transaminases and renal function creatinine 1.5 times the upper limit of normal ; Willing and able to complete the patient diary.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Highly emetogenic chemotherapy cisplatin, mechloretamine, streptozotocin, cyclophosphamide 1500 mg/sqm; carmustine; dacarbazine; hexamethylmelamine; procarbazine , or single-agent chemotherapy with drugs having low/minimal emetogenic potential according to the classification reported in the Appendix 2 ; Diagnosis of lymphoma, leukemia, or myeloma; High-dose chemotherapy; Have received any investigational drugs within 30 days before study entry; Have received any drug with potential anti-emetic efficacy with the exception of dexamethasone within 24 hours of treatment initiation; Scheduled to receive up to Day 5 after chemotherapy administration of any drug with potential antiemetic properties; Prior treatment with palonosetron; Have a seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity; Experienced vomiting or nausea in the screening phase; Brain metastases; Clinical evidence of current or impending bowel obstruction, peritonitis, infection, uremia, severe mucositis; Clinically relevant fluid and 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; Have ongoing vomiting from any organic etiology.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified