NCT00611962已完成2 期
Phase II Study of Combined Oxaliplatin and Paclitaxel for Metastatic Germ Cell Tumors
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Evaluate efficacy of oxaliplatin-paclitaxel combination using established criteria in metastatic germ cell cancer patients
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluate efficacy of oxaliplatin-paclitaxel combination using established criteria in metastatic germ cell cancer patients
时间窗: during the study conduct
次要结局
- Evaluate safety, and toxicity using established criteria,specific neurotoxicity scales, serious adverse events (SAEs) and treatment withdrawals(During the study conduct)
研究者
研究点 (1)
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