Ovarian Cancer Clinical Trial
Official title:
Germ Cell Tumour Study II
RATIONALE: Drugs used in chemotherapy, such as etoposide, carboplatin, and bleomycin, 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. Giving chemotherapy drugs before surgery may make the tumor smaller and
reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy
after surgery may kill any tumor cells that remain.
PURPOSE: This clinical trial is studying how well giving etoposide, carboplatin, and
bleomycin works in treating young patients undergoing surgery for malignant germ cell
tumors.
OBJECTIVES:
- Determine the toxic effects of etoposide, carboplatin, and bleomycin in young patients
with malignant germ cell tumors.
OUTLINE: Patients are assigned to one of two treatment arms based on their tumor type
(testicular vs ovarian, uterine, vaginal, sacrococcygeal, retroperitoneal, or thoracic).
- Group 1 (testicular tumors): Patients undergo radical orchiectomy. Patients with stage
I tumors and alpha-fetoprotein (AFP) decreasing at the expected rate receive no further
treatment unless there is a subsequent rise in the AFP or a clinical recurrence.
Patients with stage II-IV tumors receive etoposide IV over 1 hour on days 1-3,
carboplatin IV over 1 hour on day 2, and bleomycin IV over 15 minutes on day 3.
Treatment repeats every 21- 28 days for at least 4 courses in the absence of disease
progression or unacceptable toxicity. Residual teratoma may be removed, if indicated,
after completion of chemotherapy.
- Group 2 (ovarian, uterine, vaginal, sacrococcygeal, retroperitoneal, or thoracic germ
cell tumors): Patients undergo surgical removal or biopsy of the tumor. Patients then
receive etoposide, carboplatin, and bleomycin as above. Patients may then undergo
further surgery at the discretion of the principal investigator.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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