Double-blind Study to Compare the Efficacy of Palonosetron with or without the use of Dexamethasone on Days 2 and 3, in the Prevention of Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy (MEC) Given to Female Patients with Breast Cancer - PALO 05-02

Helsinn Healthcare SA0 个研究点目标入组 300 人开始时间: 2005年10月19日最近更新: 2012年3月19日

研究概览

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•Patients that meet all of the following criteria may be enrolled into the study:
•Willing and able to sign informed consent and complete the patient diary;
•Females age =18 years;
•Patients with histologically or cytologically confirmed breast cancer (BC), requiring Chemotherapy, who are naïve to chemotherapy;
•Scheduled to receive of a single dose of a MEC regimen on Day 1.
•Karnofsky Performance Status grade of =60 (see Appendix A);
•Life-expectancy greater than 3 months;
•For women of child-bearing potential, negative serum or urine pregnancy test within 2 weeks of treatment and use of physician-approved method of birth control
•throughout the study;
•Acceptable hepatic function (=2 times the upper limit of normal [ULN]) and renal
•function (creatinine =1.5 times ULN).
•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

•Prior treatment with palonosetron;
•Known hypersensitivity reaction to any 5-HT3 receptor antagonists;
•Know hypersensitivity to dexamethasone;
•Prior treatment with chemotherapy;
•Scheduled receipt of MEC, radiotherapy, or HEC (according to the Hesketh
•classification level 3 or higher) on Days 2 to 6 (see Appendix B);
•Anti-emetic therapy (within 24 hours of treatment initiation) or scheduled receipt of up to Day 5) of any drug with antiemetic effects;
•Nausea or vomiting with an National Cancer Institute (NCI) Common Toxicity
•Symptomatic brain metastases;
•Gastric outlet or intestinal obstruction;
•Known current or history of drug or alcohol abuse;
•Participation in another study within 30 days of (before or after) study entry.
•Criteria (CTC) of grade 2 or 3 in the 24 hours before receiving study medication (see Appendix C)
•Ongoing vomiting from any other organic etiology
•Female patients who are pregnant or breast feeding
•History of seizures

发起方