Phase II Study of Oxaliplatine-Paclitaxel in Patients With Metastatic Germ Cell Tumor Refractory to Cisplatin

Inclusion criteria

• Histologically proven germ cell cancer: gonadal (including ovarian) or extragonadal, seminomatous or non seminomatous, or clinical presentation of a GCT with elevated AFP level and/or hCG level (> or =to 100 x ULN) when a biopsy was not available
• Metastatic GCT patients:
• Progression disease defined as > 10% increase in hCG and/or AFP markers (and/or documented progressive disease [PD]) during a platinum-based chemotherapy or less than 6 months after the last cycle (in the case of growing non seminomatous tumor, without increased markers, a histological documentation of malignant tumor was required, to exclude growing mature teratoma)
• At least 1 prior line of chemotherapy containing CDDP + etoposide; (prior regimen with high dose chemotherapy and hematopoietic stem cell support was permitted)
• Eastern Cooperative Oncology Group PS (ECOG PS) grade < or =to 2
• At least 1 bidimensionally measurable lesion by imaging (CT scan) of > or =to 20 mm outside an irradiated area OR significantly increased tumor markers > 2 x ULN (on > or =to 2 consecutive tests, even in the absence of measurable lesions)
• Age > or =to 18
• Adequate bone marrow reserve
• Neutrophil count > or =to 1500/mm3
• Platelets > or =to 100,000/mm3
• Renal function:Creatinine < 3 x ULN
• Liver function:Transaminases < or =to 2.5 x ULN, total bilirubin < 1.5 x ULN (if liver metastases, transaminases < or =to 5 x ULN)
• Laboratory values obtained in the week preceding study entry
• Neurosensory < or =to grade 1 NCI CTC
• Signed informed consent obtained prior to all study procedures

Exclusion criteria

• Concomitant high-dose steroids (except for antiemetic prophylaxis)
• Pregnancy, breast-feeding or absence of contraception in sexually active patients
• Prior treatment with oxaliplatin or taxanes
• History of second malignancy, except for cured non melanoma skin cancer or excised in situ cervical carcinoma
• Symptomatic cerebral and/or leptomeningeal metastasis (irradiated brain metastases not requiring corticosteroid treatment were allowed)
• Treatment with another experimental drug or anticancer agent or participation in another clinical study within 30 days prior to study
• Other serious illness or uncontrolled infection
• Psychological, social or geographical situation preventing regular follow-up
• Primary tumor in brain/central nervous system