Phase II Study of Combined Oxaliplatin and Paclitaxel for Metastatic Germ Cell Tumors
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