Obligatory Post-Registration Open-Label, Non-Comparative Multicenter Study of Efficacy and Tolerance Rate of Caelyx as Monotherapy in Patients With Epithelial Ovarian Cancer, Resistant to Previous Platinum Therapy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Number of Participants With Complete Response
研究概览
简要总结
The aim of this study is to evaluate efficacy and tolerability, and number of positive response to treatment with CAELYX (50 mg/m^2), administered as monotherapy once per 4 weeks to patients with metastatic epithelial ovarian cancer, resistant to previous platinum therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent and/or parent or legal guardian must have signed a written informed consent.
- •Women must be greater than or equal to 18 years of age, of any race.
- •Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
- •Morphology (cytology or histology) confirmed diagnosis of epithelial ovarian cancer.
- •Patients with 1 or more measurable and/or evaluable tumors, according to the results of CT, MRT scans or X-ray, etc.
- •Patients, including those after primary surgical treatment, who had previously received platinum chemotherapy and in whom second-line therapy is indicated.
- •Karnofsky performance status above 60%.
- •Left ventricular ejection fraction above 50% (according to the results of echocardiography).
- •Adequate bone marrow function as indicated by:
- •Platelets >100x10^9/L
- •Haemoglobin > 9 g/dL
- •Absolute neutrophil count >1.5x10^9/L
- •Adequate renal function as indicated by:
- •Serum creatinine < 1.5 х ULN
- •Adequate liver function as indicated by:
- •Bilirubin level and AST or ALT activity < 2 х ULN (with the exception of cases related to primary disease).
排除标准
- •Women who are pregnant or nursing.
- •Subjects who have not observed the designated washout periods for any of the prohibited medications.
- •Subjects who have used any investigational product within 30 days prior to enrollment.
- •Medical history indicating serious concomitant diseases, such as congestive heart failure of II NYHA class or higher, insulin-dependent diabetes mellitus, clinically significant liver disease, mental disorders.
- •Non-controlled bacterial, viral or fungal infections.
- •Conditions and reasons (medical, social and psychological) that might prevent adequate follow-up of patients.
- •Any other active primary tumor under treatment (except basal or squamous cell carcinoma or in situ cervix carcinoma).
- •Patient has symptomatic metastasis to brain.
研究组 & 干预措施
Arm 1
Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
干预措施: Pegylated Liposomal Doxorubicin hydrochloride (Drug)
结局指标
主要结局
Number of Participants With Complete Response
时间窗: 4 weeks after chemotherapy completed
Complete response was defined as complete disappearance of all measurable and assessable disease with no new disease or disease-related symptoms as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
Number of Participants With Partial Response
时间窗: 4 weeks after chemotherapy completed
Required 50 percent or greater decrease in sum of products of all bidimensionally measurable lesions without progression of assessable disease and no new lesions as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
Number of Participants With Stabilization
时间窗: 4 weeks after chemotherapy completed
All other subjects (except complete or partial responders and those with progression \[see prior definitions\]) were classified as stable disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
Number of Participants With Progression
时间窗: 4 weeks after chemotherapy completed
Progressive disease was defined as 25% or greater increase in the size of measurable lesion. The reappearance of any lesion or clear worsening of assessable disease or the appearance of any new lesion was also considered as progressive disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
次要结局
- Mean Time to Positive (Partial) Treatment Response Achievement(from the beginning of study drug administration up to 4 weeks after chemotherapy completed)
- Median Time to Progression(from the beginning of study drug administration up to 4 weeks after chemotherapy completed)
- Mean Survival Time During the Study(from the beginning of study drug administration up to 18 months)