Trial Information

Summary: A Phase II Study to Assess the Safety and Efficacy of AloxiŽ (Palonosetron HCI) for the Prevention of Nausea and Vomiting in Patients Receiving Consecutive Daily Doses of Cisplatin Therapy for Testicular Cancer

The purpose of this research study is to find out what effects (good or bad) palonosetron (AloxiŽ) can have on the nausea and vomiting caused by testicular cancer chemotherapy treatment. The Food and Drug Administration (FDA) approved palonosetron in July 2003 for the prevention of acute (occurring within 24 hours of the start of chemotherapy) and delayed (occurring from 24 to 120 hours after the start of chemotherapy) nausea and vomiting associated with certain types of chemotherapy.

Inclusion criteria:

• Age = 18 years
• Histologically or serogically confirmed germ cell tumors including extragonadal as well as testicular cancer
• Karnofsky index = 50%
• Scheduled to receive a regimen containing cisplatin at a dose of 20 mg/m² on Study Days 1 through 5 including:
  • etoposide (100 mg/m²) and cisplatin (20 mg/m²) Days 1-5
  • bleomycin (30 units weekly), etoposide (100 mg/m²) and cisplatin (20 mg/m²) days 1-5
  • etoposide (75 mg/m²), ifosfamide (1.2 g/m²) and cisplatin (20 mg/m²) Days 1-5

Exclusion criteria:

• Received an investigational drug within 30 days before study entry
  • Received any drug with potential antiemetic efficacy within 24 hours prior to the start of chemotherapy on Study Day 1 or are scheduled to receive or anticipate the use of any drug of this type during the trial
• Previous treatment with palonosetron (AloxiŽ)
• Any vomiting, retching or National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, version 3.0, grade 2-4 nausea in the 24 hours preceding chemotherapy
• Ongoing vomiting for any organic etiology
• Received, or will receive, radiotherapy of upper abdomen or cranium or total body irradiation within one week prior to or during the study

If you would like to learn more about participating in this study, please send an e-mail message using the form below.