NCT01379989已完成3 期
Phase III International, Randomized Study of Trabectedin Plus Pegylated Liposomal Doxorubicin (PLD) Versus Carboplatin Plus PLD in Patients With Ovarian Cancer Progressing Within 6-12 Months of Last Platinum
Mario Negri Institute for Pharmacological Research132 个研究点 分布在 6 个国家目标入组 617 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 617
- 试验地点
- 132
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The objective of this multicentric, randomised, Phase III study is to demonstrate superiority, in terms of survival, of trabectedin and Pegylated Liposomal Doxorubicin (PLD) versus carboplatin and PLD in partially-platinum sensitive ovarian cancer patients.
详细描述
Patients will be randomised to:
Arm A: PLD 30 mg/m2 and carboplatin AUC 5; Arm B: PLD 30 mg/m2 and trabectedin 1.1 mg/m2. Patients' characteristics: patients over 18 years of age with advanced, progressive ovarian cancer 6-12 months after completion of first line or second line treatment with platinum-based chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged ≥ 18 years
- •Histologically and/or cytologically proven epithelial ovarian, epithelial fallopian tube cancer or primary peritoneal cancer
- •Progression free interval between six and twelve (6-12) months (calculated from the first day of the last cycle of the last platinum-based chemotherapy until the date of progression confirmation through radiologic imagery). Patients may have received up to two platinum-based chemotherapy lines, of which at least one must have contained a taxane
- •Measurable or evaluable disease confirmed by radiological imaging, such as magnetic resonance imaging (MRI), computed tomography (CT) scan, or PET/CT scan at study entry (CA-125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression) or histological proven recurrent ovarian cancer even in the absence of postoperatively measurable or evaluable lesions.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
- •Estimated life expectancy ≥ 12 weeks
- •Patients must be accessible for treatment and follow-up
- •Adequate organ function within 14 days prior to first cycle as evidenced
- •Patients must be able to receive dexamethasone or its equivalent, which is required if randomly assigned to treatment with trabectedin plus PLD
- •Informed consent of the patient
排除标准
- •Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)
- •Patients who did not respond to last platinum-based therapy or in whom last relapse occurred < 6 months or > 12 months from the last dose of platinum
- •Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases
- •Pre-existing grade > 1 motor or sensory neuropathy according to the National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.0
- •Myocardial infarct within six months before enrolment, New York Association (NYHA) Class II or worse heart failure (Appendix
- •The New York Heart Association), uncontrolled angina, severe uncontrolled ventricular arrythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- •History of liver disease
- •Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
- •Breastfeeding women and women of child bearing potential must use effective contraception during treatment and 3 months thereafter, which may include prescription contraceptives (oral, injection, or patch), intrauterine device, double-barrier method or male partner sterilization (not applicable to patients that are surgically sterile)
- •Prior exposure to trabectedin
- •Prior resistance to anthracyclines or PLD defined as a progression during anthracycline-based chemotherapy or a recurrence within 6 months from its ending
- •Prior severe PLD related toxicity
- •Prior exposure to cumulative doses of doxorubicin >400mg/m2 or epirubicin >720mg/m2
- •Treatment with any investigational product within 30 days prior to inclusion in the study
研究组 & 干预措施
Carboplatin plus PLD
Active Comparator
Pegylated Lipoxomal Doxorubicin (PLD) 30 mg/ m2 followed by carboplatin AUC 5.
干预措施: Carboplatin (Drug)
Carboplatin plus PLD
Active Comparator
Pegylated Lipoxomal Doxorubicin (PLD) 30 mg/ m2 followed by carboplatin AUC 5.
干预措施: Pegylated Lipoxomal Doxorubicin (PLD) (Drug)
Trabectedin plus PLD
Experimental
Pegylated Lipoxomal Doxorubicin (PLD) 30 mg/m2 infusion followed by trabectedin 1.1 mg/m2 infusion.
干预措施: Pegylated Lipoxomal Doxorubicin (PLD) (Drug)
Trabectedin plus PLD
Experimental
Pegylated Lipoxomal Doxorubicin (PLD) 30 mg/m2 infusion followed by trabectedin 1.1 mg/m2 infusion.
干预措施: Trabectedin (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled
This is an event driven study. The study will continue until 442 events have occurred.
次要结局
- Time to subsequent chemotherapy administration(This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- CA-125 serological response(This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- OS for Subsequent chemotherapies(This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- Best response to each Subsequent chemotherapy line(This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- Duration of Response(This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- Frequency of toxicities leading to dose delays(This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- Frequency of toxicities leading to treatment discontinuation(This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- Progression Free Survival (PFS)(This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- Objective RR(This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- PFS for the Subsequent Chemotherapies(This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- Frequency of serious adverse events (SAEs)(This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- QoL according to the EORTC QLQ-C30 and QLQ-OV28(This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- Frequency of toxicities, graded according to the NCI-CTAE version 4.0(This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- Frequency of toxicities leading to dose modifications(This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint)
研究者
研究点 (132)
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