Germ Cell Tumors
Study A
ECOG 3894
Randomized Multi-Institutional Phase III Trial Of BEP
And High Dose Chemotherapy Versus BEP Alone In Previously
Untreated Patients With Poor Risk Germ Cell Tumors.
Objectives:
- To compare the efficacy of two cycles of bleomycin,
etoposide and cisplatin (BEP) plus two cycles of
high-dose carboplatin, etoposide and cyclophosphamide
with autologous bone marrow or stem cell reinfusion to 4
cycles of BEP alone in previously untreated germ cell
tumor patients with poor risk features.
- To compare the toxicity associated with early dose
intensification with high-dose chemotherapy and
autologous bone marrow/stem cell transplantation compared
with standard chemotherapy of 4 cycles of BEP in
previously untreated poor risk germ cell tumor patients.
- To prospectively evaluate the rate of decline of
serum tumor markers human chorionic gonadotrophin (HCG)
and alpha fetoprotein (AFP) in patients in both arms of
the study for use as post-treatment prognostic
indicators. This will be correlated with complete
response and survival.
Eligibility:
1. Patients must be male with poor risk, nonseminomatous
germ cell tumors (NSGCT). Poor risk is defined as having one
or more of the following:
a. Testicular or retroperitoneal primary site without
visceral metastases but with one of the following poor
markers:
i. pretreatment serum LDH > 10 times the upper limit
of normal
ii. pretreatment serum HCG > 10,000 ng/ml
iii. pretreatment serum AFP > 10,000 ng/ml
b. Testicular or retroperitoneal primary site with one or
more nonpulmonary visceral metastases, regardless of the
serum tumor markers, to bone, brain, liver, skin, or other
nonpulmonary visceral site.
c. Primary mediastinal NSGCT regardless of serum tumor
marker values.
2. Patients must be at least 12 years of age.
3. Patients must have measurable or evaluable disease.
4. Patients must not have received prior chemotherapy
treatment.
5. Patients must have adequate renal, hepatic, pulmonary
and hematologic function.
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