Trial | NCT00276718  Report issue

Title

Etoposide, Carboplatin, and Bleomycin in Treating Young Patients Undergoing Surgery For Malignant Germ Cell Tumors
Germ Cell Tumour Study II

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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.
Study Started
Apr 30
1989
Last Update
Sep 17
2013
Estimate

Biological bleomycin sulfate

Drug carboplatin

Drug etoposide

Procedure conventional surgery

Criteria 

DISEASE CHARACTERISTICS:

Histologically proven malignant germ cell tumors at all stages

Testicular tumors

Stage I - Confined to testes
Stage II - Confined to testes and retroperitoneal/abdominal lymph nodes
Stage III - Supradiaphragmatic nodal disease (mediastinal and/or supraclavicular)
Stage IV - Extralymphatic spread (liver, lung, bone, brain, skin, etc.)

Ovarian, uterine, vaginal, and sacrococcygeal tumors

Stage I - Confined to ovary/uterus/vagina/pre- and postsacral area
Stage II - Spread limited to the pelvis
Stage III - Spread limited to the abdomen (excluding liver)
Stage IV - Spread to liver or beyond the abdominal cavity

Abdominal, retroperitoneal, and thoracic primary tumors

Stage I - Confined to site of origin and resectable
Stage II - Local spread
Stage III - Extensive spread confined to one side of the diaphragm (excluding the liver)
Stage IV - Tumor spread to the liver, to both sides of the diaphragm, and/or to bones, bone marrow, brain, etc.
Intracranial germ cell tumor cases allowed even if an alternative protocol is being followed

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

No prior chemotherapy
No Results Posted