DISEASE CHARACTERISTICS: Histologically or serologically confirmed metastatic germ cell
neoplasm (gonadal or extragonadal primary) that cannot be cured with either surgery or
chemotherapy Seminomas, nonseminomas, or ovarian germ cell tumors allowed If
histologically confirmed, requires one or more of the following: Metastatic lesions on
chest x-ray or CT scan Rising serum HCG or AFP If only evidence of progressive disease,
then two additional consecutive determinations must exhibit serologic progression Only
eligible if alternative causes for increased serum levels are absent Failed initial
cisplatin combination chemotherapy (generally bleomycin/etoposide/cisplatin,
cisplatin/etoposide, cisplatin/vinblastine, or similar regimens) Failed and demonstrated
progressive disease following the administration of at least one "salvage" regimen for
advanced germ cell neoplasms Failed no more than three prior regimens defined as: 25%
increase in the product of perpendicular diameters of measurable tumor masses during prior
therapy, new lesions OR Increasing AFP or HCG Disease progression during initial induction
chemotherapy or with primary mediastinal nonseminomatous germ cell tumors can be treated
with paclitaxel plus gemcitabine as second-line therapy (initial salvage chemotherapy)
PATIENT CHARACTERISTICS: Age: 15 and over Performance status: ECOG 0-2 Hematopoietic: WBC
at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT no greater than 4
times normal Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.5 mg/dL
Other: No active uncontrolled infection Not pregnant or nursing Fertile patients must use
effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy:
Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered
Surgery: At least 3 weeks since major surgery and recovered Other: At least 1 week since
prior intravenous antibiotics No concurrent intravenous antibiotics
OBJECTIVES: I. Evaluate the effect of gemcitabine plus paclitaxel on response rate, duration
of remission, and survival in patients with refractory germ cell tumors. II. Evaluate the
toxic effects of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 1 hour followed by gemcitabine IV over 30
minutes on days 1, 8, and 15 of each 4 week course. Treatment is repeated for a maximum of
six courses in the absence of unacceptable toxicity or disease progression. Patients are
followed every 3 months for 2 years, every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: Approximately 44 patients will be accrued over 19 months for this study.
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