NCT00080002终止2 期
Effectiveness and Safety Study of Pegamotecan (PEG-Camptothecin) in Patients With Locally Advanced or Metastatic Cancer of the Stomach or Gastroesophageal Junction Who Have Relapsed or Progressed Following a Previous Chemotherapy Treatment
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of pegamotecan (PEG-camptothecin) in patients with pathologically-diagnosed locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction who have relapsed or progressed following one prior chemotherapy treatment regimen.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed diagnosis of adenocarcinoma of the stomach or gastroesophageal junction.
- •Disease measurable in at least one dimension.
- •Target tumors outside of prior radiation field(s).
- •An Eastern Cooperative Oncology Group (ECOG) performance scale score of 0 or 1
- •Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil count.
- •Adequate renal function, as determined by serum creatinine and serum albumin measurements.
- •Adequate liver function, as determined by total bilirubin and transaminases levels. Transaminases may be <= 5.0x ULN if due to metastatic disease in the liver.
- •Fully recovered from prior surgery.
- •No history of hemorrhagic cystitis.
- •No microscopic hematuria (>10 RBC/hpf) unless documented to be due to an infection or non-bladder origin.
- •Capable of understanding the protocol requirements and risks and providing written informed consent.
排除标准
- •Concurrent serious medical illness unrelated to tumor within the past 6 months.
- •Known chronic infectious disease, such as AIDS or hepatitis (screening for hepatitis and HIV will not be performed).
- •Positive screening pregnancy test or is breast-feeding.
- •Female or male subject of reproductive capacity who is unwilling to use methods appropriate to prevent pregnancy during the course of this study.
- •Receiving concurrent chemotherapy, investigational agents, radiotherapy, surgery, or has received wide field radiation within the previous 4 weeks.
- •History of another malignancy (except basal and squamous cell carcinomas of the skin and carcinoma in situ of the cervix) within the last 5 years.
- •Known or clinically suspected brain metastases.
- •Received more than one prior regimen of chemotherapy for locally advanced or metastatic adenocarcinoma of the stomach or GE junction.
- •Received prior neoadjuvant and/or adjuvant cytotoxic chemotherapy
- •Received any investigational drug within the last 30 days.
- •Not fully recovered from any prior, and from any reversible side effects related to the administration of cytotoxic chemotherapy, investigational agents, or radiation therapy.
- •Prior treatment with a camptothecin analog.
研究者
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