Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 4/2/2016 |
| Start Date: | November 2003 |
A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors
RATIONALE: Drugs used in chemotherapy 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.
PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy
regimens to see how well they work in treating patients with stage II or stage III
non-seminomatous germ cell tumors.
cells, either by killing the cells or by stopping them from dividing. Giving more than one
drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy
regimens to see how well they work in treating patients with stage II or stage III
non-seminomatous germ cell tumors.
OBJECTIVES:
- Compare progression-free survival rates of patients with poor prognosis stage II or III
non-seminomatous germ cell tumors with an unfavorable decrease of tumor markers after
treatment with 1 course of bleomycin, etoposide, and cisplatin followed by subsequent
treatment with 3 additional courses of bleomycin, etoposide, and cisplatin OR
dose-dense sequential combination chemotherapy.
- Compare overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study.
Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients with a
favorable decrease of tumor markers after 1 course of BEP receive 3 additional courses of
BEP. Patients with an unfavorable decrease of tumor markers after 1 course of BEP are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive 3 additional courses of BEP.
- Arm II: Patients receive dose-dense sequential combination chemotherapy comprising
cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.
PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study.
- Compare progression-free survival rates of patients with poor prognosis stage II or III
non-seminomatous germ cell tumors with an unfavorable decrease of tumor markers after
treatment with 1 course of bleomycin, etoposide, and cisplatin followed by subsequent
treatment with 3 additional courses of bleomycin, etoposide, and cisplatin OR
dose-dense sequential combination chemotherapy.
- Compare overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study.
Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients with a
favorable decrease of tumor markers after 1 course of BEP receive 3 additional courses of
BEP. Patients with an unfavorable decrease of tumor markers after 1 course of BEP are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive 3 additional courses of BEP.
- Arm II: Patients receive dose-dense sequential combination chemotherapy comprising
cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.
PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
- Diagnosis of non-seminomatous germ cell tumors (NSGCT) as evidenced by 1 of the
following criteria:
- Histologically confirmed NSGCT
- Clinical evidence of disease AND high serum human chorionic gonadotropin (HCG)
or alpha-fetoprotein (AFP) levels
- Clinical stage II-III disease (disseminated disease)
- Testicular, retroperitoneal, or mediastinal primary site
- Poor prognosis disease, meeting 1 of the following criteria:
- Mediastinal primary site
- Non-pulmonary visceral metastases
- One of the following lab values:
- HCG > 50,000 UI/L
- AFP > 10,000 ng/mL
- Lactate dehydrogenase > 10 times upper limit of normal (ULN)
PATIENT CHARACTERISTICS:
Age
- Over 16
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times ULN
Renal
- Creatinine clearance > 60 mL/min
Other
- No other prior malignancy except basal cell skin cancer
- No HIV positivity
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
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