NCT00144378已完成3 期
Randomized Phase III Study With Irinotecan+Best Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- median survival
研究概览
简要总结
The median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 2.5 months. There are no data which a possible benefit of second line therapy. for this reason a trial which investigates a possible benefit or chemotherapy compared to best supportive care as second line treatment is urgently necessary.
Irinotecan shows response rates of 20% in the first line therapy with high rates od disease stabilization. There are few trials investigating irinotecan in the second line setting. Response rates of 20% are reported in tis setting. Irinotecan is supplied without costs from the company Pfizer.
详细描述
Metastatic gastric cancer, progressive disease after one palliative chemotherapy
Arm A:
Irinotecan 250/350 mg/m2 q3w
- Cycle:250mg/m2/ 30min
- Cycle:If no toxicity>2° CTC, nor Leuko-thrombopenia>3° occured, dose is increased to 350mg/m2 Arm B. Best supportive care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with histologically proven adenocarcinoma of stomach or the gastro-esophageal junction
- •Patient with distant metastases laparoscopically proven operative incurability of an locally advanced gastric cancer or patient with a tumor recurrence after gastrectomy
- •Patient with progressive disease under a palliative first-line chemotherapy or progressive disease within 6 months after termination of a first-line chemotherapy, defined as objective progression by imaging techniques according to WHO criteria
- •Age 18 and 75 years
- •Sufficient liver function, defined as serum-bilirubin <1,5 mg/dl (1,5 upper normal limit), ALT und AST < 3x upper normal limit
- •Sufficient renal function, defined as serum creatinine < 1,25 x upper normal limit or creatinine clearance >60ml/min calculated according to Crockroft-Gault
- •Contraction for patient with reproductive potential
- •Karnofsky-Index >60%
- •Measurable or evaluable tumor manifestation
排除标准
- •Tumor progression later than 6 months after termination of first-line chemotherapy
- •KI 50% or less
- •Patient who have already received a second line chemotherapy for the metastatic setting (adjuvant chemotherapy and one line of palliative chemotherapy os allowed, biologic prior therapies are allowed)
- •Prior or current second malignancy despite of basal carcinoma of the skin and curatively treated carcinoma in situ of the cervix
- •Uncontrolled infection
- •CNS metastases
- •Other severe medical illness
- •Prior major surgery less than 2 weeks ago
- •Parallel treatment with another experimental therapy
- •Parallel treatment with another therapy aiming at tumor reduction
- •Chronic diarrhea, subileus
- •Chronic inflammatory bowel disease or intestinal obstruction
- •Pretreatment with irinotecan
结局指标
主要结局
median survival
次要结局
- quality of life, response rates, time to tumor progression, toxicity
研究者
研究点 (1)
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