Randomized Phase II Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors
16 Years
N/A
Male
Extragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor
Trial Information
Randomized Phase II Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors
OBJECTIVES:
Primary
- Compare the response rate in patients with poor-prognosis extracranial nonseminoma germ
cell tumors treated with intensive induction chemotherapy comprising cisplatin,
vincristine, bleomycin, and carboplatin followed by bleomycin, etoposide phosphate, and
cisplatin (BEP) vs standard BEP chemotherapy.
Secondary
- Compare overall and progression-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a multicenter, open-label, randomized study. Patients are stratified
according to participating center, pre-protocol low-dose chemotherapy (yes vs no), and other
clinically important factors. Patients are randomized to 1 of 2 treatment arms.
- Arm I (BEP): Patients receive bleomycin IV over 15 minutes once on day 1 or 2 and days
8 and 15 and etoposide phosphate IV over 1 hour and cisplatin IV over 4 hours on days
1-5. Treatment repeats every 21 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II (CBOP/BEP): Patients receive chemotherapy according to the following schedule:
- Weeks 1-6: Patients receive cisplatin IV over 6 hours on days 1, 2, 8, 15, 16, and
22 (OR over 4 hours on days 1-5 and 15-19); vincristine IV on days 1, 8, 15, 22,
29, and 36; bleomycin IV over 15 minutes on days 1, 15, 29, and 36 and bleomycin
IV continuously on days 8-12 and 22-25; and carboplatin IV over 30-60 minutes on
days 8 and 22.
- Weeks 7-15: Patients receive bleomycin IV continuously on days 1-5, 8-12, and
15-19 and etoposide phosphate IV over 1 hour and cisplatin IV over 4 hours on days
1-5. Treatment repeats every 21 days for 4 courses.
After completion of study treatment, patients are followed periodically for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Nonseminoma germ cell tumor of any extracranial primary site diagnosed by 1 of the
following methods:
- Histologic confirmation
- Alpha-fetoprotein (AFP) > 1,000 ng/mL or human chorionic gonadotropin (hCG) >
5,000 IU/L with appropriate clinical picture in a man < 45 years of age
- Poor prognosis features as defined by ≥ 1 of the following:
- AFP > 10,000 ng/mL
- hCG > 50,000 IU/L
- Lactic dehydrogenase > 10 times normal
- Nonpulmonary visceral metastases
- Mediastinal primary site
PATIENT CHARACTERISTICS:
- Male
- WHO performance status 0-3
- Glomerular filtration rate > 50 mL/min
- Less than 50 mL/min eligible if due to obstructive neuropathy that can be
relieved by stenting or nephrostomy
- No comorbid condition that would prevent treatment
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy except low-dose chemotherapy to stabilize disease before study
therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rates to treatment
Safety Issue:
No
Principal Investigator
Robert A. Huddart, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
Unspecified
Study ID:
CDR0000456203
NCT ID:
NCT00301782
Start Date:
June 2005
Completion Date:
Related Keywords:
- Extragonadal Germ Cell Tumor
- Teratoma
- 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
- testicular yolk sac tumor and teratoma
- stage I malignant testicular germ cell tumor
- stage II malignant testicular germ cell tumor
- stage III malignant testicular germ cell tumor
- recurrent malignant testicular germ cell tumor
- recurrent extragonadal non-seminomatous germ cell tumor
- stage I extragonadal non-seminomatous germ cell tumor
- stage II extragonadal non-seminomatous germ cell tumor
- stage III extragonadal non-seminomatous germ cell tumor
- stage IV extragonadal non-seminomatous germ cell tumor
- recurrent extragonadal germ cell tumor
- testicular immature teratoma
- testicular mature teratoma
- adult teratoma
- Teratoma
- Neoplasms, Germ Cell and Embryonal
Name | Location |
|---|
