EUCTR2008-000245-55-DE进行中（未招募）不适用
Phase II Study Evaluating PegLiposomal Doxorubicin (PLD) and Carboplatin Combination Chemotherapy in Gynecological Sarcomas and Mixed Epithelial-Mesenchymal Tumors
GYN Research GmbH0 个研究点开始时间: 2008年4月16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
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
- •Patients treated according to this protocol must meet all of the following criteria:
- •- Histologically documented mesenchymal or mixed epithelial-mesenchymal tumor of the ovary or uterus.
- •- Patients with a primary diagnosis of FIGO I-IV uterine carcinosarcoma and optimum debulking (postoperative residual tumor < 1cm) may be enrolled only if cisplatin-ifosfamide combination therapy is not feasible.
- •- Patients with metastatic uterine carcinosarcoma may be enrolled only if phosphamide-paclitaxel combination therapy is not feasible.
- •- Patients with metastatic leiomyosarcoma may be enrolled only if gemcitabine-docetaxel combination therapy is not feasible.
- •- Measurable (target lesion) tumor, evaluable (non-target lesion) tumor or histological documentation
- •- No more than one prior chemotherapy. Any prior platinum or anthracycline-containing chemotherapy must have been completed more than 6 months previously.
- •- Prior radiotherapy <= 25% of the hematopoietic system is allowed provided it took place more than 6 weeks before recruitment.
- •- Patients are allowed to have received prior anticancer hormone therapy or specific immunotherapy. Patients must have completed these therapies at least three weeks before recruitment to the study
- •- All women with a theoretical possibility of pregnancy must produce a negative pregnancy test (serum or urinary) within seven days before starting treatment.
- •- General health of 0 - 2 on the ECOG score
- •- At least 18 years of age
- •- Estimated life expectancy above 12 weeks
- •- At least 3 weeks since major surgery
- •- Appropriate hematologic, renal and hepatic function in accordance with the following definitions:
- •-Absolute neutrophil count (ANC) >= 1.5 * 10^9 /l
- •-Platelets >= 100 * 10^9/l
- •-Total bilirubin <= 1.25 times upper limit of normal
- •-Estimated GFR >= 50 ml/min
- •- LVEF >= 50 %
- •- Informed consent must be obtained from all patients.
- •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
- •Patients treated according to this protocol must not meet any of the following criteria:
- •- More than one prior chemotherapy (or radiochemotherapy)
- •- Active infection or other serious medical impairment liable to affect the patient's ability to receive treatment according to protocol.
- •- Administration of other chemotherapy drugs or other anticancer hormone treatments during the study.
- •- History of clinically manifest atrial or ventricular arrhythmia (> LOWN II) and congestive heart failure, even if controlled by drugs (NYHA class > II). Documented myocardial infarction within 6 months before study enrollment.
- •- Pregnant or breastfeeding women, or women not practicing appropriate birth control methods.
- •- Participation in another study using experimental drugs within the last 30 days
- •- Any other conditions or therapies which the physician believes might put the patient at risk or impair the study objective.
- •- known hypersensitivity to carboplatin or pegylated liposomal doxorubicin
研究者
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