EUCTR2004-005181-20-ES进行中（未招募）1 期
A randomized, parallel group, open-label, active controlled, multicenter Phase III trial of Patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil/Caelyx) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancer
ovartis Farmacéutica, S.A0 个研究点目标入组 0 人开始时间: 2005年12月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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
- •- Histologically confirmed diagnosis of epithelial ovarian, primary fallopian or primary peritoneal cancer.
- •- No more than one prior taxane/platinum-based combination chemotherapy regimen at the initial platinum dose of carboplatin AUC 5-6 or cisplatin 75mg/m2
- •- Taxane/platinum refractory/resistant patients must present with either measurable (by RECIST criteria) or non-measurable (CA-125 by Rustin criteria) progressive disease
- •- Left ventricular ejection fraction (LVEF) >/= 50% by MUGA or 2-D echocardiography
- •- Age > 18 years.
- •- WHO performance status of 0, 1, or 2.
- •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 with CA-125-only disease
- •- Unresolved bowel obstruction
- •- Prior administration of and/or known hypersensitivity to: epothilones, anthracyclines and/or pegylated liposomal doxorubicin
- •- Any peripheral neuropathy > CTC grade 1
- •- Unresolved diarrhea of any grade within last 7 days prior to start of treatment.
- •- Presenting with leptomeningeal involvement
- •- Within 3 weeks of receiving any prior chemotherapy or radiotherapy or who are planning to receive either while participating in the study
- •- Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease
- •- History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or cervical cancer in situ
- •- Receiving hematopoietic growth factors (except erythropoietin)
- •- Concomitant administration of Coumadin® or other agents containing warfarin
- •- Concomitant administration of any drug/agent known to cause, or increase the severity of, diarrhea
- •Concomitant administration of any drug/agent known to interact negatively with doxorubicin or pegylated liposomal doxorubicin
研究者
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A randomized, parallel group, open-label, active controlled, multicenter Phase III trial of Patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil/Caelyx) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal canceradvanced epithelial ovarian cancerMedDRA version: 14.1Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2004-005181-20-ITOVARTIS FARMA810
进行中（未招募）
1 期
A randomized, parallel group, open-label, active controlled, multicenter Phase III trial of Patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil/Caelyx) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancerApproximately 75% of women with ovarian cancer present advanced disease. Survival is highly dependent on the stage of disease at the initiation of treatment. Recommended first-line therapy is a combination of platinum drug and paclitaxel. Patients who progress during primary therapy or within 6 months after are considered platinum refractory/resistant. The prognosis of patients with resistant / refractory ovarian cancer is uniformly poor with median overall survival ranging from 35 – 41 weeksEUCTR2004-005181-20-GRovartis Pharma Services AG
进行中（未招募）
不适用
A randomized, parallel group, open-label, active controlled, multicenter Phase III trial of Patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil/Caelyx) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancerApproximately 75% of women with ovarian cancer present advanced disease. Survival is highly dependent on the stage of disease at the initiation of treatment. Favorable prognostic factors include young age, cell type other than clear cell or mucinous, lower stage, good performance status, small residual tumor volume after surgery, and absence of ascites. The prognosis of patients with resistant / refractory ovarian cancer is uniformly poor with median overall survival ranging from 35 – 41 weeks.EUCTR2004-005181-20-HUovartis Pharma Services AG810
进行中（未招募）
不适用
A randomized, parallel group, open-label, active controlled, multicenter Phase III trial of Patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil/Caelyx) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancerApproximately 75% of women with ovarian cancer present advanced disease. Survival is highly dependent on the stage of disease at the initiation of treatment. Recommended first-line therapy is a combination of platinum drug and paclitaxel. Patients who progress during primary therapy or within 6 months after are considered platinum refractory/resistant. The prognosis of patients with resistant / refractory ovarian cancer is uniformly poor with median overall survival ranging from 35 – 41 weeksEUCTR2004-005181-20-DKovartis Pharma Services AG810
已完成
3 期
A randomized, parallel group, open-label, active controlled, multicenter Phase III trial of Patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil/Caelyx) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancerNL-OMON31592ovartis8