NCT00189566已完成2 期
National, Randomized, Phase II Study Comparing Efficacy of Weekly Administration of Paclitaxel in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse
ARCAGY/ GINECO GROUP2 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2004年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Progression-free survival of patients in the three groups
研究概览
简要总结
This study will look at the efficacy and safety of weekly administration of paclitaxel (Taxol®) in monotherapy compared to paclitaxel in combination with topotecan or carboplatin in patients with ovarian cancer in early relapse.
详细描述
The main purpose of this research study is to find out if treatment of early relapse of ovarian or fallopian tube or peritoneal cancer with paclitaxel (Taxol*) weekly administered, in lower doses in combination with topotecan (Hycamtin*) or carboplatin will improve efficacy compared to weekly administration of paclitaxel in monotherapy. Tolerance in the three groups will be compared.
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
- •Patients aged > 18
- •Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneum
- •Peritoneal and/or nodes and/or visceral metastases
- •Disease in progression under treatment or within 6 months after a first or second platinum-based line
- •A period of 3 weeks between last chemotherapy and inclusion
- •Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup [GCIG] criteria)
- •ECOG performance status < 2
- •Life expectancy of at least 12 weeks
排除标准
- •Previously received weekly administration of paclitaxel chemotherapy
- •Involved in a trial within the last 30 days
- •Previously received a bone marrow autogreffe or irradiation of the abdomen within 5 years, due to intensive chemotherapy
- •Prior diagnosis of malignancy
- •History of ischemic cardiopathy, congestive heart failure (New York Heart Association [NYHA] > 2), arrhythmia, hypertension, or significant valvulopathy
- •Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade > 2
- •Bone marrow, renal, or hepatic insufficiency
- •Severe active infection or occlusive or sub-occlusive disease
- •History of symptomatic brain metastases
- •Fertile women not using adequate contraceptive methods
- •Pregnant or breast feeding women
- •Hypersensitivity to compounds chemically related to paclitaxel, topotecan, or carboplatin
结局指标
主要结局
Progression-free survival of patients in the three groups
次要结局
- Overall survival
- Rate of response and rate of progression at the end of treatment
- Qualitative and quantitative toxicities
- Quality of life
研究者
研究点 (2)
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