A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors
16 Years
N/A
Both
Extragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor
Trial Information
A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival rate after 1 course of treatment
Safety Issue:
No
Principal Investigator
Karim Fizazi, MD, PhD
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
Unspecified
Study ID:
CDR0000416124
NCT ID:
NCT00104676
Start Date:
November 2003
Completion Date:
Related Keywords:
- Extragonadal Germ Cell Tumor
- Teratoma
- Testicular Germ Cell Tumor
- stage II malignant testicular germ cell tumor
- stage III malignant testicular germ cell tumor
- testicular choriocarcinoma and embryonal carcinoma
- testicular choriocarcinoma and teratoma
- testicular choriocarcinoma and yolk sac tumor
- testicular choriocarcinoma
- testicular embryonal carcinoma and teratoma
- testicular embryonal carcinoma and yolk sac tumor
- testicular embryonal carcinoma
- testicular yolk sac tumor and teratoma
- testicular yolk sac tumor
- stage II extragonadal non-seminomatous germ cell tumor
- stage III extragonadal non-seminomatous germ cell tumor
- testicular immature teratoma
- testicular mature teratoma
- adult teratoma
- Teratoma
- Neoplasms, Germ Cell and Embryonal
Name | Location |
|---|---|
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
