EUCTR2006-002116-10-IT进行中（未招募）不适用
Carboplatin Gemcitabine as second line treatment in platinum sensitive advanced ovarian cancer phase II study on a new schedule. - ND
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点目标入组 32 人开始时间: 2006年11月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1 Histologically proven ovarian cancer with evidence of recurrence or progression, which is not amenable to curative surgery or radiotherapy 2 Failed first-line platinum-containing therapy after at least 6 months of platinum discontinuation even if the first-line therapy included maintenance treatment . The standard for first-line treatment in ovarian cancer chemotherapy is the combination of platin derivatives and paclitaxel. In this study, inclusion can be extended to patients not treated with this standard because a the standard was different at the time of first line therapy and the patient is not eligible for taxanes therapy, and/or b the patients had not been treated with standard chemotherapy for other reasons, such as toxicity. The patient must, however, be pre-treated with platinum. 3 Documented lesion as evidenced by appropriate computerized tomography CT , or magnetic resonance imaging MRI scan, chest x ray, or ultrasound. Physical examination is allowed for lymph nodes. A physical gynecological examination of well-defined palpable tumor lesions is also permitted. Patients must have evaluable disease outside of the previously irradiated area. 4 Previous radiotherapy must be terminated at least 3 weeks before study drug administration.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •11 Clinical evidence of central nervous system CNS metastases. 14 A second primary malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin . 17 Received more than one previous chemotherapy regimen or had prior gemcitabine treatment. 19 Patients with estimated GFR 50 mL/min
研究者
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