NCT00030862已完成2 期
Phase II Single-Arm Trial Of CPT-11 (Irinotecan HC1; Camptosar Injection)/Cisplatin In Patients With Advanced Esophageal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and cisplatin in treating patients who have locally advanced unresectable or metastatic cancer of the esophagus that has not been previously treated.
详细描述
OBJECTIVES:
- Determine the objective tumor response rate in patients with previously untreated locally advanced unresectable or metastatic esophageal cancer treated with irinotecan and cisplatin.
- Determine the dysphagia relief in patients treated with this regimen.
- Determine the time to progression and overall survival of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 1-2 hours and irinotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus
- •Previously untreated
- •Locally advanced unresectable or metastatic disease
- •More than 50% of tumor must involve esophagus or gastroesophageal (GE) junction if tumor extends below the GE junction into the proximal stomach
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR
- •At least 10 mm by spiral CT scan
- •The following are not considered measurable disease:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusions
- •Lymphangitis cutis/pulmonis
- •Abdominal masses not confirmed and followed by imaging techniques
- •Cystic lesions
- •Tumor lesions in previously irradiated areas
- •No carcinomatous meningitis or untreated brain metastases
- •Brain metastases allowed if asymptomatic and patient is on stable or tapering dose of steroids
- •Large pleural effusions must have been previously drained and sclerosed or otherwise controlled
- •Small, stable, asymptomatic pleural effusions allowed
- •Dysphagia allowed
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- •No known Gilbert's disease
- •Creatinine no greater than 1.5 mg/dL
- •Calcium less than 12.0 mg/dL
- •Cardiovascular:
- •No history of significant cardiovascular disease
- •No inadequately controlled hypertension
- •No unstable angina
- •No myocardial infarction within the past 6 months
- •No ventricular cardiac arrhythmias requiring medication
- •No history or treatment for congestive heart failure
- •No interstitial pneumonia
- •No fibroid lung
- •No serious active infection
- •No uncontrolled diabetes mellitus (random blood sugar at least 300 mg)
- •No peripheral neuropathy grade 2 or greater
- •No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other malignancy that does not carry a worse prognosis than advanced esophageal cancer
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排除标准
- 未提供
研究者
研究点 (1)
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