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

Study Overview
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Brief Summary
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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

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

Conditions
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Neoplasms, Germ Cell and Embryonal

Intervention / Treatment
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* Drug: Oxaliplatin, Paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxaliplatin, Paclitaxel|Oxaliplatin was provided in clear glass vials sealed with a rubber stopper and an aluminum seal with a flip-off cover. Each vial contained 50 or 100 mg of active ingredient with 450 or 900 mg, respectively, of lactose monohydrate as excipient Paclitaxel was supplied as single dose vials of 30 mg/5 mL or 100 mg/17 mL.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate efficacy of oxaliplatin-paclitaxel combination using established criteria in metastatic germ cell cancer patients |  | during the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate safety, and toxicity using established criteria,specific neurotoxicity scales, serious adverse events (SAEs) and treatment withdrawals |  | During the study conduct |