NCT00109096已完成2 期
A Randomized, Double-Blind Phase 2 Study of Two Doses of Pemetrexed in the Treatment of Platinum-Resistant, Epithelial Ovarian or Primary Peritoneal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 21
- 主要终点
- To assess the anti-tumor activity, as measured by tumor response rate (proportion of patients with complete or partial response, of 500 mg/m2 vs. 900 mg/m2 of pemetrexed therapy administered every 21 days
研究概览
简要总结
The purposes of this study are to determine: - whether standard or higher doses of pemetrexed should be given to patients with ovarian or primary peritoneal cancer that has recurred; - the safety and side effects of standard and higher doses of pemetrexed given to patients with ovarian or primary peritoneal cancer that has recurred; - whether standard or higher doses of pemetrexed can help patients with ovarian or primary peritoneal cancer that has recurred.
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
- Double
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
- •Patient must have been diagnosed with ovarian or primary peritoneal cancer
- •Patient must have had 1 or 2 prior platinum-based chemotherapeutic regimens.
- •Patient must have adequate health status.
- •Patient compliance and geographic proximity that allow for adequate follow up is required.
- •Signed informed consent from the patient or legal representative is required.
排除标准
- •Patient is pregnant or breast-feeding
- •Patient has received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •Patient has previously participated in another study investigating pemetrexed.
- •Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, and corticosteroids.
- •Patient cannot be taking nonsteroidal anti-inflammatory drugs around the time of administration of study drug.
结局指标
主要结局
To assess the anti-tumor activity, as measured by tumor response rate (proportion of patients with complete or partial response, of 500 mg/m2 vs. 900 mg/m2 of pemetrexed therapy administered every 21 days
次要结局
- Time to response
- Duration of response
- Time to objective progressive disease (TtPD)
- Time to treatment failure (TtTF)
- Objective PFS
- OS
- To assess safety and toxicity profile of two doses of pemetrexed in patients with ovarian cancer
研究者
研究点 (21)
Loading locations...
相似试验
已完成
2 期
Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.NCT00447057Eli Lilly and Company204
已完成
不适用
A randomised phase II study of pemetrexed compared to pemetrexed-carboplatin in pretreated patients with advanced NSCLCiet Kleincellig Long Carcinoom (NSCLC)NL-OMON26799VALT/Vrije Universiteit Medical CentreAmsterdam230
已完成
2 期
Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT00269152Eli Lilly and Company122
已完成
2 期
A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung CancerNon Small Cell Lung CancerNCT00606021Eli Lilly and Company106
Unknown
2 期
Pemetrexed vs Pemetrexed Plus Cisplatin in EGFR-mutant NSCLC Patients After First Line EGFR-TKIs FailureNon-small Cell Lung CancerNCT02725918Guangdong Association of Clinical Trials150