NCT00102414已完成3 期
A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy
AGO Study Group0 个研究点目标入组 356 人开始时间: 1999年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 356
- 主要终点
- Time to progressive disease
研究概览
简要总结
The primary objective of this study is to compare the time to progressive disease in patients treated with gemcitabine plus carboplatin versus carboplatin monotherapy. Patients will have advanced epithelial ovarian cancer and have failed first-line platinum-containing therapy 6 months after treatment discontinuation.
详细描述
Carboplatin is commonly used for the treatment of ovarian cancer in first- and second-line therapy. The efficacy of gemcitabine in ovarian carcinoma was researched in various Phase 2 studies.
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
- •Histologically proven ovarian cancer with evidence of recurrence or progression
- •Failed first-line platinum containing therapy after 6 months of treatment discontinuation
- •Documented lesion as evidenced by appropriate computerized tomography (CT), magnetic resonance imaging (MRI) scan, chest x-ray, or ultrasound.
- •Previous hormonal therapy or radiotherapy must be terminated at least 3 weeks before study drug administration
- •Adequate bone marrow reserve: neutrophils ≥ 1.5 x 10^9/L and platelets ≥ 100 x 10^9/L
排除标准
- •Receiving concomitant cytotoxic or other antineoplastic treatment. Hormone replacement therapy is allowed, as are steroid antiemetics
- •Clinical evidence of central nervous system metastases
- •Active infection
- •Cannot adequately be followed up for the duration of the study
- •A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- •Use of any investigational agent in the 3 weeks prior to inclusion
- •Serious concomitant systematic disorders incompatible with the study
- •Received more than one previous chemotherapy regimen or had prior gemcitabine treatment
- •Patients with tumor of borderline malignancy
- •Patients with estimated GFR ≤ 50 mL/min
结局指标
主要结局
Time to progressive disease
次要结局
- Duration of response
- Response rate
- Quality of Life
- Survival time
- Toxicity
研究者
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