Clinical trial NCT00611962: Phase II Study of Oxaliplatine-Paclitaxel in Patients With Metastatic Germ Cell Tumor Refractory to Cisplatin
Official title: Phase II Study of Combined Oxaliplatin and Paclitaxel for Metastatic Germ Cell Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms, Germ Cell and Embryonal
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-02-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Indianapolis tumor marker (human chorionic gonadotropin \[hCG\], alpha fetoprotein \[AFP\]) criteria in metastatic germ cell cancer patients


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate efficacy of oxaliplatin-paclitaxel combination using established criteria in metastatic germ cell cancer patients
timeFrame: during the study conduct
Secondary outcomes:
measure: Evaluate safety, and toxicity using established criteria,specific neurotoxicity scales, serious adverse events (SAEs) and treatment withdrawals
timeFrame: During the study conduct
Other outcomes:
Locations:
city: Lyon
country: France
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Nathalie Billon
role: STUDY_DIRECTOR
References: