Phase II Study of Irinotecan (CPT-11) in Adenocarcinoma of the Esophagus and Gastric Cardia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 25
- 主要终点
- To determine the antitumor activity of irinotecan hydrochloride (CPT-11) in patients with unresectable adenocarcinoma of the esophagus and gastric cardia who have failed prior chemotherapy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have esophageal or stomach cancer.
详细描述
OBJECTIVES: I. Determine the antitumor activity of irinotecan in patients with adenocarcinoma of the esophagus or gastric cardia. II. Evaluate the toxicities of this drug in this patient population.
OUTLINE: This is a multicenter study. Patients receive irinotecan intravenous (IV) over 90 minutes once a week for 4 weeks followed by a 2 week rest period. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patients must be > 18 years of age
- •Patients must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- •Patients must have a predicted life expectancy of at least 12 weeks
- •Patients must have a pretreatment granulocyte count of >1500/mm3, a hemoglobin level of >9.0 gm/dL and the platelet count of >100000/mm3
- •Patients must have adequate renal function as documented by a serum creatinine < 2.0 mg/dL
- •Patients must have adequate hepatic function as documented by a serum bilirubin < 1.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor. Aspartate transaminase must be < 3 x institutional upper limit of normal unless the liver is involved with tumor, in which case the aspartate transaminase must be < 5 x institutional upper limit of normal
- •Patients must have histologically proven adenocarcinoma of the esophagus or gastric cardia with progression despite prior chemotherapy
- •Patients must have disease radiologically measurable bidimensionally
- •Patients must have an interval of 4 weeks from prior chemotherapy, immunotherapy, or radiation therapy
排除标准
- •Patients with any active or uncontrolled infection
- •Patients with psychiatric disorders that would interfere with consent or follow-up
- •Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy
- •Patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years
- •Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- •Presence of clinically apparent central nervous system metastases or carcinomatous meningitis
- •Patients with uncontrolled diabetes mellitus
- •Patients with any other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- •Prior therapy with a deoxyribonucleic acid (DNA) topoisomerase inhibitor
- •Patients with known Gilbert's syndrome
研究组 & 干预措施
irinotecan hydrochloride
One course of therapy is comprised of a 4-week treatment period and a two-week rest period. Drug administration will be based on actual calculated body surface area. Starting dose will be 125 mg/m2/day given once per week on four consecutive weeks.
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
To determine the antitumor activity of irinotecan hydrochloride (CPT-11) in patients with unresectable adenocarcinoma of the esophagus and gastric cardia who have failed prior chemotherapy
时间窗: 2 years
次要结局
- Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population(2 years)