An Open-label, Randomised Phase II Study of Fludarabine With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and toxicity of fludarabine with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant or refractory ovarian cancer.
详细描述
Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. Approximately 75% of patients are diagnosed at an advanced stage will eventually experience disease recurrence. The overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. The 5-year overall survival rates are less than 20%. Therefore, it is important to seek alternative agent that can improve the outcome. Fludarabine is a purine nucleoside analog prodrug that upon phosphorylation is toxic to dividing and quiescent lymphocytes and monocytes, exerting its effects through DNA synthesis interference and apoptosis. The preclinical studies suggest fludarabine may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of the study drug fludarabine combined with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant or refractory ovarian cancer.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
- •Platinum resistant or refractory ovarian cancer
- •At least treated with one line of platinum-based chemotherapy
- •Female, age ≥18 years and ≤70 years, signed informed consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version
- •Patients must have a life expectancy of at least 3 months.
- •Patients must have adequate organ function as defined by the following criteria:
- •White blood cell count ≥ 3 x 10^9/L, Absolute neutrophil count (ANC) (≥ 1.0 x 10^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 80 x 10^9/L
- •Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN
- •Serum creatinine ≤ 1 x ULN
- •Symptomatic central nervous system (CNS) metastasis
- •Exclusion Critera:
- •Has known allergies to any of the excipients.
- •Prior treatment with adriamycin or other anthracycline at cumulative doses greater than 550 mg/m2 after 6 cycles of pegylated liposomal doxorubicin
- •LVEF (left ventricular ejection fraction) <50%
- •Had disease recurrence/progression within 6 months after the administration of doxorubicin chemotherapy
- •History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day
- •Known significant chronic liver disease, such as cirrhosis or active hepatitis
- •Uncontrollable active infection
排除标准
- 未提供
研究组 & 干预措施
Arm 1: Fludarabine and Pegylated liposomal doxorubicin
干预措施: Fludarabine and Pegylated liposomal doxorubicin (Drug)
Arm 2: Pegylated liposomal doxorubicin
干预措施: Pegylated liposomal doxorubicin (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Up to four years
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD
次要结局
- Objective response rate(Up to four years)
研究者
Jundong Li
Professor
Sun Yat-sen University