Status:
COMPLETED
Phase II Study of Oxaliplatine-Paclitaxel in Patients With Metastatic Germ Cell Tumor Refractory to Cisplatin
Lead Sponsor:
Sanofi
Conditions:
Neoplasms, Germ Cell and Embryonal
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy of the oxaliplatin-paclitaxel combination i.e. evaluation of tumor response rate using World Health Organization/Union Internationale Contre le Cancer (WHO/UICC) and Indianapo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00611962
Start Date
December 1 2000
End Date
March 1 2004
Last Update
February 11 2008
Active Locations (1)
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1
Sanofi-Aventis
Lyon, France