NCT00782041终止2 期
Phase II Study of Oxaliplatin in Combination With 5-fluorouracil (5-FU) and Folinic Acid (FA) in Patients Who Have Failed First-line Treatment for Locally Advanced or Metastatic Cervical Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Primary:
- To assess the overall response rate of oxaliplatin in patients with bidimensionally measurable disease at baseline.
Secondary:
- To assess the safety and tolerability of oxaliplatin
- To assess time to progression and overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Have Locally advanced/metastatic squamous or adenocarcinoma of the cervix
- •Prior therapy with cisplatin allowed
- •First-line treatment may have been surgery,radiotherapy or chemotherapy either as a single agent or multi-modality therapy
- •Must have measurable disease
- •Histologically Proven Carcinoma of the cervix
- •ECOG PS ≤2
- •No other serious concomitant illness
- •Fully recovered from any prior therapy
- •Lab: ANC >1500 mm³, Platelets > 100000 mm³, Creatinine ≤ 1.5 x Normal value, Bilirubin ≤ 1.5 x Normal value, SGPT (ALT) ≤ 2.5 x Normal value
排除标准
- •Known allergy to one of the study drugs
- •Peripheral neuropathy > grade2
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
Oxaliplatin 85 mg/m² over 3 hours at Day 1 and Day 15. 5-FU 2,000 mg/m² over 4 hours at Day 1. Folinic acid 20 mg/m² Bolus at Day 1.
干预措施: Oxaliplatin (Drug)
1
Experimental
Oxaliplatin 85 mg/m² over 3 hours at Day 1 and Day 15. 5-FU 2,000 mg/m² over 4 hours at Day 1. Folinic acid 20 mg/m² Bolus at Day 1.
干预措施: 5-FluoroUracil (Drug)
1
Experimental
Oxaliplatin 85 mg/m² over 3 hours at Day 1 and Day 15. 5-FU 2,000 mg/m² over 4 hours at Day 1. Folinic acid 20 mg/m² Bolus at Day 1.
干预措施: Folinic acid (Drug)
结局指标
主要结局
Response rate
时间窗: Throughout the study period
次要结局
- Overall survival(Throughout the study period)
- Progression-free survival(Throughout the study period)
- Adverse events(Throughout the study period)
研究者
研究点 (1)
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