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

I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY0 个研究点目标入组 330 人开始时间: 2006年10月3日最近更新: 2012年3月19日

适应症

试验速览

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•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

•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.

发起方

I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY