Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors

OBJECTIVES:

• Determine the efficacy of chemotherapy comprising paclitaxel, ifosfamide, and cisplatin in combination with pegfilgrastim in patients with previously untreated intermediate- or poor-risk germ cell tumors.
• Determine the safety of this regimen in these patients.
• Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 120-180 minutes on days 1 and 2, cisplatin IV over 30 minutes and ifosfamide IV over 120 minutes on days 1-5, and pegfilgrastim subcutaneously on day 6. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Some patients may required surgery after chemotherapy and, if viable non-teratomatous germ cell tumor is found in the surgical specimen and there is no interval disease progression, these patients may receive 1-2 more courses of chemotherapy after surgery.

After completion of study treatment, patients are followed up at 28 days and then every 2 months for up to 1 year.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed germ cell tumor meeting 1 of the following criteria:

• Poor risk, defined by any of the following:

• Testis or retroperitoneal primary site nonseminoma histology without visceral metastases but with "poor-risk" markers, defined by any of the following:

• Pretreatment serum lactate dehydrogenase (LDH) > 10 times upper limit of normal (ULN)
• Pretreatment serum human chorionic gonadotropin (HCG) > 50,000 IU/L
• Pretreatment serum alpha fetoprotein (AFP) > 10,000 ng/mL
• Testis or retroperitoneal primary site nonseminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values):

• Bone metastases
• Brain metastases
• Hepatic metastases
• Any nonpulmonary metastases (i.e., skin, spleen)
• Mediastinal primary site nonseminoma histology regardless of serum tumor marker levels or presence/absence of visceral metastases
• Modified intermediate risk, defined by any of the following:

• Testis or retroperitoneal primary site nonseminoma histology with no nonpulmonary visceral metastases, and with any of the following serum marker values:

• Pretreatment serum LDH 3.0-10 times ULN
• Pretreatment serum HCG 5,000-50,000 IU/L
• Pretreatment serum AFP 1,000-10,000 ng/mL
• Seminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values or primary site):

• Bone metastases
• Brain metastases
• Hepatic metastases
• Any nonpulmonary visceral metastases (i.e., skin, spleen)
• Previously untreated disease
• Measurable or evaluable disease

PATIENT CHARACTERISTICS:

• WBC ≥ 3,000/mm^3
• Platelet count ≥ 100,000/mm^3
• Creatinine normal or creatinine clearance > 50 mL/min (unless renal dysfunction is due to tumor obstructing the ureters)
• AST and ALT ≤ 3 times ULN
• Bilirubin ≤ 2.0 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No concurrent malignancy except for nonmelanoma skin cancer
• No known HIV positivity
• No active infections

PRIOR CONCURRENT THERAPY:

• Recovered from prior surgery
• More than 30 days since prior radiotherapy and recovered (unless evidence of progressive disease has been documented)
• No prior chemotherapy
• No other concurrent cytotoxic therapy
• Concurrent radiotherapy and surgery allowed for treatment of brain metastases