NCT00562185撤回1 期
A Phase I/II Study of Intravenous Doxil and Intraperitoneal Carboplatin as Salvage Therapy in Patients With Recurrent Ovarian Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of intraperitoneal carboplatin when given in combination with IV doxorubicin hydrochloride (phase I)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving doxorubicin together with carboplatin may kill more tumor cells.
PURPOSE: This phase I and phase II trial is studying the side effects and best dose of carboplatin when given together with doxorubicin to see how well it works in treating patients with recurrent ovarian cancer.
详细描述
OBJECTIVES:
Primary
- To determine the maximum tolerated dose and safety of intravenous doxorubicin hydrochloride and intraperitoneal carboplatin in patients with platinum-sensitive recurrent ovarian cancer.
- To evaluate the feasibility of this regimen in these patients.
Secondary
- To evaluate the response rate and progression-free survival of patients with recurrent ovarian cancer who have had no more than two prior salvage regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ovarian carcinoma
- •Recurrent disease
- •Known platinum-sensitive recurrent disease after no more than 2 prior salvage regimens
- •Measurable disease as defined by a target lesion and a CA125 level
- •No epithelial ovarian carcinoma of low malignant potential
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •GOG performance status 0, 1, or 2
- •Life expectancy > 6 months
- •Absolute neutrophil count ≥ 1,500/uL
- •Platelet count ≥ 100,000/uL
- •Hemoglobin > 9.0 g/dL
- •Creatinine ≤ 2.0 mg/dL
- •Bilirubin ≤ 1.5 x upper limit of normal (ULN)
- •SGOT and alkaline phosphatase ≤ 3 x ULN
- •Neuropathy (sensory and motor) ≤ CTCAE grade 1
排除标准
- •GOG performance status 3 or 4
- •Pregnant or breastfeeding
- •History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or the components of DOXIL®
- •Abnormal LVEF as determined by gated cardiac radionucleotide scan (MUGA)
- •Septicemia or severe infection
- •Acute hepatitis or severe gastrointestinal bleeding
- •Any of the following:
- •Unstable angina
- •Myocardial infarction within the past 6 months
- •NYHA class II-IV heart failure
- •Uncontrolled angina
- •Severe uncontrolled ventricular arrhythmias
- •Clinically significant pericardial disease
- •Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- •Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if their disease has been stable for the past six months
- •Other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Inclusion criteria:
- •See Disease Characteristics
- •At least 6 months since prior adjuvant regimen
- •At least 4 weeks since prior salvage treatment
- •May have received secondary cytoreduction for recurrent ovarian cancer
- •May have received prior intraperitoneal therapy for ovarian cancer
- •May have received no more than 2 prior platinum and taxane-based regimens
- •May have received prior intraperitoneal platinum during front-line treatment
- •Exclusion criteria:
- •Prior anthracycline dose exceeding 360 mg/m^2 for doxorubicin hydrochloride (including DOXIL®) or 720 mg/m^2 for epirubicin hydrochloride
- •Prior radiotherapy
- •Prior intraperitoneal carboplatin or cisplatin as salvage treatment for recurrent ovarian cancer
- •Concurrent amifostine or other protective agents
结局指标
主要结局
Maximum tolerated dose of intraperitoneal carboplatin when given in combination with IV doxorubicin hydrochloride (phase I)
Acute toxicity
Primary efficacy and safety (phase II)
次要结局
未报告次要终点
研究者
研究点 (1)
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