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