Ovarian Cancer Clinical Trial
Official title:
Phase II Trial of Paclitaxel, Ifosfamide, and Cisplatin in Previously Untreated Intermediate and Poor Risk Germ Cell Tumor Patients
RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor
cells. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune
cells found in bone marrow or peripheral blood and may help the immune system recover from
the side effects of chemotherapy.
PURPOSE: This phase II trial is studying the side effects and how well giving combination
chemotherapy together with pegfilgrastim works in treating patients with previously untreated
germ cell tumors.
OBJECTIVES:
- 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.
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