Phase III Multicenter Study in Epithelial Ovarian Carcinoma FIGO Stage IIB-IV Comparing Treatment With Paclitaxel and Carboplatin to Paclitaxel and Carboplatin Sequentially Followed by Topotecan

AGO Study Group33 个研究点分布在 1 个国家目标入组 900 人开始时间: 1999年12月1日最近更新: 2006年8月4日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 900
试验地点: 33
主要终点: Survival

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether the triple combination of Carboplatin, Paclitaxel and Topotecan has a superior clinical outcome in the treatment of ovarian cancer compared with the combination of Carboplatin and Paclitaxel.

详细描述

Carboplatin-Paclitaxel is the current standard in the first-line treatment of advanced ovarian cancer. One option to further improve the therapeutic results is the incorporation of a third, non-cross-resistant drug into first line chemotherapy of advanced ovarian cancer. In two separate, single center phase II studies, a different combination of the three active agents (Carboplatin, Paclitaxel and Topotecan) has been tested. In these studies, Carboplatin and Paclitaxel were given at standard doses and schedules, followed sequentially by Topotecan which was well tolerated at a dose of 1.25 mg/m2/day given for five days and repeated every 21 days. The prolonged therapy is not associated with cumulative toxicity and the compliance of the patients was good.

Study Hypothesis/Comparison: The triple combination (Carboplatin/Paclitaxel/Topotecan) yields superior outcome in the treatment of first-line ovarian cancer compared with the combination of Carboplatin + Paclitaxel

研究设计

研究类型: Interventional
分配方式: 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

•Histologically proven epithelial carcinoma of the ovary or of the fallopian tube or extraovarian papillary serous carcinoma with extent to the ovary
•International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IV, regardless of measurable or non-measurable disease
•No prior chemo- or radiotherapy
•Adequate hematologic, renal and hepatic function:
•ANC ≥ 1.5 x 10^9/L,
•Platelet counts ≥ 100 x 10^9/L,
•Total bilirubin ≤ 1.5 x upper normal limit,
•Alkaline Phosphatase ≤ 3 x upper normal limit,
•Serum creatinine ≤ 1.25 upper normal limit,
•Estimated GFR ≥ 60 ml/min
•Performance status 0-2 (ECOG)
•Life expectancy must be greater than 12 weeks

排除标准

•Non-epithelial tumors or mixed epithelial/non-epithelial tumors (e.g. mixed Mullerian tumors) or tumors of low malignant potential (borderline tumors)
•Prior treatment with chemo- or radiotherapy
•Administration of other simultaneous chemotherapeutic drugs or hormonal therapy or simultaneous radiotherapy during the study treatment period or planned whole abdominal radiotherapy
•History of congestive heart failure
•Symptomatic brain metastasis
•Complete bowel obstruction
•Active infection or other serious underlying medical condition
•Pre-existing motor or sensory neurologic pathology

结局指标

主要结局

Survival

次要结局

Progression-free survival
Response rate
Response duration
Toxicities
Quality of Life

研究者

发起方

AGO Study Group

申办方类型

Other

研究点 (33)

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