Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors

OBJECTIVES:

Primary

• Determine the feasibility of accelerated treatment comprising bleomycin, etoposide, cisplatin, and pegfilgrastim in men with metastatic germ cell tumors.
• Determine the toxicity of this regimen (particularly with respect to renal, pulmonary, and neurological function) in these patients.

Secondary

• Determine the response rate in patients treated with this regimen.
• Determine the progression-free survival of patients treated with this regimen.

OUTLINE: This is a non-randomized, pilot study.

Patients receive etoposide IV on days 1-3, cisplatin IV on days 1 and 2, and bleomycin IV over 2 hours on days 2, 6, and 10. Patients also receive pegfilgrastim subcutaneously on day 4. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Patients must fulfill all of the following criteria for 1 of the following diagnoses:

• Nonseminoma germ cell tumor (intermediate risk)

• Testis or retroperitoneal primary
• Abnormal markers (alpha fetoprotein [AFP] > 1,000 and < 10,000 ng/mL, human chorionic gonadotropin [HCG] > 5,000 and < 50,000 IU/L, lactate dehydrogenase [LDH] > 1.5 times and < 10 times upper limit of normal [ULN])
• No liver, bone, brain, or other nonpulmonary visceral metastasis
• Histologic confirmation is not required if AFP or HCG are grossly elevated
• Nonseminoma germ cell tumor (poor prognosis) meeting 1 of the following criteria:

• Mediastinal primary
• Nonpulmonary visceral metastases
• Poor markers (AFP > 10,000 ng/mL, HCG > 50,000 IU/L, LDH > 10 times ULN)
• Histologic confirmation not required if AFP or HCG are grossly elevated
• Seminoma (intermediate prognosis)

• Histological confirmation is required
• Any primary site
• Nonpulmonary visceral metastases must be present
• Normal AFP
• Any HCG
• Any LDH
• Surveillance relapse

• Must fulfill appropriate criteria above according to initial histology

PATIENT CHARACTERISTICS:

• Neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Must have adequate renal function (creatinine clearance ≥ 60 mL/min)
• No prior malignancy except basal cell carcinoma

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy