NCT01224652Unknown3 期
A Randomized, Multicenter Phase III Study to Assess the Efficacy of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 518
- 试验地点
- 2
- 主要终点
- progression-free survival
研究概览
简要总结
The primary objectives of this study is to compare the efficacy of paclitaxel monotherapy with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first line therapy.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed gastric adenocarcinoma in tissue/cell
- •Recurrent or metastatic gastric cancer that has progressed following first- line therapy
- •Patients must be ≥18 years of age.
- •ECOG performance status ≤ 2
- •At least one lesion (measurable or non-measurable but evaluable) according to RECIST criteria
- •Normal organ and bone marrow function measured within 2 weeks prior to administration of study treatment as defined below: Haemoglobin ≥ 9.0 g/dL White blood cells (WBC) ≥ 3000/µL Absolute neutrophil count (ANC) ≥ 1500/µL Platelet count ≥ 100 x 103/µL Total bilirubin ≤ 1.5 x upper normal limit (UNL) Creatinine clearance ≥ 60 ml/min or Serum creatinine ≤ 1.5 x UNL AST (SGOT)/ALT (SGPT) ≤ 2.5 x UNL unless liver metastases are present in which case it must be ≤ 5x UNL
- •Life expectancy ≥ 12 weeks.
- •Written informed consent
- •Provision of informed consent for genetic research (In case of optional genetic research)
排除标准
- •More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.
- •Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
- •Any previous treatment with a taxane, including paclitaxel and docetaxel or irinotecan, in the metastatic or recurrent setting.
- •Patients with second primary cancer, except: adequately treated non- melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years.
- •Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used).
- •Ongoing toxicities (>CTCAE grade 2) caused by previous cancer therapy.
- •Clinically proven gastric outlet obstruction or CTCAE grade 3 or grade 4 upper GI bleeding
- •Medically uncontrolled, clinically significant heart disease or infection
- •Patients with symptomatic uncontrolled brain metastases.
- •Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
- •Women who have pregnancy potential or willing to pregnant. Pregnant and breastfeeding women.
- •Others Poor medical risk due to a serious, uncontrolled medical disorder, non- malignant systemic disease or active, uncontrolled infection Any psychiatric disorder that prohibits obtaining informed consent and regular follow-up. Inappropriate patient for subjects of this study on investigator's judgment
研究组 & 干预措施
paclitaxel
Experimental
Paclitaxel 70 mg/m2 on Days 1, 8 and 15 of a 28-day cycle
干预措施: Paclitaxel (Drug)
irinotecan
Experimental
irinotecan 150 mg/m2 on Days 1 and 15 of a 28-day cycle
干预措施: Irinotecan (Drug)
结局指标
主要结局
progression-free survival
时间窗: every 8 weeks
Tumor evaluation using RECIST v1.1
次要结局
- Safety(up to 4 weeks after last administration of chemotherapy)
- Overall survival(1 year)
研究者
研究点 (2)
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