Open-Label Pilot Study to Evaluate the Efficacy of Palonosetron Associated with Aprepitant (Emend) and Dexamethasone in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy (HEC) - PALO-05-01

Helsinn Healthcare SA0 sites60 target enrollmentOctober 10, 2005

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: This is a Phase 4, open-label, pilot study to evaluate the Efficacy of Plaonosetron associated with Aprepitant (Emend) and Dexamethasone in preventing nausea and vomitting in chemotherapy-naïve patients, 18 years or older receiving a Highly Emetogenic Chemotherapy (HEC) regimen containing cisplatin =70 mg/m2.
Sponsor: Helsinn Healthcare SA
Enrollment: 60
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

October 10, 2005

End Date

February 19, 2007

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•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;
•Males and females age \=18 years;
•Patients with histologically or cytologically confirmed malignant disease, requiring chemotherapy, who are naïve to chemotherapy;
•Scheduled to receive a single dose of a HEC regimen containing cisplatin \=70 mg/m2 on Day 1 (Note: cisplatin may be given in combination with other chemotherapy agents);
•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

•Patients will be excluded from participation in the study if they have:
•Prior treatment with palonosetron;
•Known hypersensitivity reaction to any 5\-HT3 receptor antagonists;
•Known hypersensitivity reaction to aprepitant;
•Know hypersensitivity to dexamethasone;
•Prior treatment with chemotherapy;
•Scheduled receipt of MEC or HEC (according to the Hesketh classification level 3 or higher) on Days 2 to 6 (see Appendix B); or scheduled radiotherapy on Days 1 to 6\.
•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 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;