A Randomized Phase III Study of Paclitaxel, Ifosfamide and Cisplatin Versus Vinblastine, Ifosfamide and Cisplatin as Second-Line Therapy for Patients With Relapsed/Resistant Germ Cell Tumors

Date de début de l'étude : 1 avril 2004

DISEASE CHARACTERISTICS: * Histologically confirmed germ cell tumor (GCT), including 1 of the following primary tumor sites: * Seminoma * Testis * Retroperitoneum * Mediastinum * Other extragonadal site * Nonseminoma * Testis * Retroperitoneum * Other extragonadal site * No tumor of the mediastinum * Must have evidence of metastatic disease, including either of the following: * Unidimensionally measurable lesions * At least 20 mm by conventional techniques (e.g., physical exam for clinically palpable lymph nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions surrounded by aerated lung) OR at least 10 mm by spiral CT scan or MRI * Nonmeasurable lesions, including the following: * Small lesions * Bone lesions * Pleural or pericardial effusions * Ascites * Irradiated lesions, unless progression is documented after radiotherapy * Progressive or recurrent disease meeting at least 1 of the following criteria: * Measurable progressive disease * Biopsy-proven residual disease * Persistently elevated or rising ß-human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) titers with no other clear cause for elevation * Previously treated with 1 and only 1 regimen comprising etoposide and cisplatin with or without bleomycin AND exhibits clinical resistance by at least 1 of the following conditions after therapy\*: * Progressive GCT after a partial response to first-line therapy * Relapse after complete response (CR) to first-line therapy, including partial response (PR) surgically converted to CR * Second testicular primary with evidence of metastases after first-line therapy * Relapse after adjuvant chemotherapy NOTE: \*Patients failing to achieve PR or CR with first-line therapy as evidenced by rising markers or new disease within 4 weeks of first-line therapy are not eligible PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL (transfusion allowed) Hepatic * Bilirubin ≤ 1.5 times upper limit of normal\* (ULN) * AST and ALT ≤ 2.5 times ULN\* NOTE: \*Unless hepatic metastases are present Renal * Creatinine ≤ 1.5 times ULN OR * Creatinine clearance ≥ 50 mL/min Other * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No prior dose-intensive therapy with stem cell replacement Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy * No prior paclitaxel * No prior docetaxel * No prior ifosfamide * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 3 weeks since prior radiotherapy * Concurrent or sequential radiotherapy to brain metastases allowed * No other concurrent palliative radiotherapy Surgery * See Disease Characteristics * Concurrent surgery for brain metastases allowed Other * Recovered from prior therapy