Phase II Trial of Paclitaxel, Ifosfamide, and Cisplatin in Previously Untreated Intermediate and Poor Risk Germ Cell Tumor Patients
- Determine the efficacy of chemotherapy comprising paclitaxel, ifosfamide, and cisplatin
in combination with pegfilgrastim in patients with previously untreated intermediate-
or poor-risk germ cell tumors.
- Determine the safety of this regimen in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 120-180 minutes on days 1 and 2, cisplatin IV
over 30 minutes and ifosfamide IV over 120 minutes on days 1-5, and pegfilgrastim
subcutaneously on day 6. Treatment repeats every 21 days for up to 4 courses in the absence
of disease progression or unacceptable toxicity.
Some patients may required surgery after chemotherapy and, if viable non-teratomatous germ
cell tumor is found in the surgical specimen and there is no interval disease progression,
these patients may receive 1-2 more courses of chemotherapy after surgery.
After completion of study treatment, patients are followed up at 28 days and then every 2
months for up to 1 year.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of complete response
At the completion of therapy
Darren Feldman, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|