Phase II Study of Paclitaxel Plus Gemcitabine in Refractory Germ Cell Tumors

Inclusion Criteria

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