NCT00165464已完成2 期
A Phase II Trial of Taxotere, Cisplatin, and Irinotecan in Advanced Esophageal and Gastric Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- To assess the response rate of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan (CPT-11).
研究概览
简要总结
This is a phase II study of taxotere, cisplatin and irinotecan (CPT-11) used in combination to treat metastatic esophageal and gastric cancer in an effort to see what effects (good and bad) the combination may have on the patients cancer.
详细描述
- Taxotere, cisplatin and irinotecan will be administered to the patient once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks).
- Patients will also receive corticosteroids, intravenous hydration and anti-emetic therapy prior to each treatment.
- A physical exam and bloodwork will be done each week of the treatment and every 2 cycles, reassessment of the tumor by the same imaging method to determine the baseline size will be conducted.
- Patients will remain on the study unless disease progression or intolerable toxicity occur.
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
- •Histologically confirmed, incurable esophageal or gastric carcinoma (carcinoma = adenocarcinoma or squamous cell carcinoma)
- •Measurable disease > 1cm (longest diameter) by spiral CT scan or > 2cm by other radiographic technique.
- •Lesions must be measurable in at least one dimension.
- •Bone lesions, ascites and effusions are not measurable.
- •Irradiated lesions are not measurable yet lesions arising in previously irradiated fields are measurable.
- •Age 18+ years.
- •ECOG performance status 0 or
- •Life expectancy greater than 12 weeks.
- •Adequate bone marrow function.
- •Adequate renal function: creatinine equal to or less than 1.5 mg/dl.
- •SGOT less than 2.5 x institutional upper limit of normal if alkaline phosphatase is within institutional upper limit of normal.
- •Alkaline phosphatase less than 4.0 x upper limit of normal if SGOT is within institutional upper limit of normal.
- •For patients with both SGOT and alkaline phosphatase elevations, SGOT must be less than 1.5 x institutional upper limit of normal and alkaline phosphatase must be less 2.5 x institutional upper limit of normal. For patients with liver metastases, however, SGOT may be < 3.0 x institutional upper limit of normal and alkaline phosphatase may be < 5.0 x institutional upper limit of normal as long as the total bilirubin is within the institutional upper limit of normal.
排除标准
- •No prior chemotherapy (except as part of pre- or post-operative therapy, completed > 1 year prior to start date of this protocol).
- •Patients who have received prior pelvic radiation therapy are ineligible. Other prior radiation therapy, however, is permitted, provided at least 4 weeks have elapsed since completion of this therapy and the initiation of this protocol.
- •No myocardial infarction in the past six months.
- •No major surgery in the past three weeks.
- •No uncontrolled serious medical or psychiatric illness.
- •No uncontrolled diarrhea.
- •Patients with a peripheral neuropathy > grade 1 will be excluded.
- •Women of childbearing potential must have a negative pregnancy test. Men and women of childbearing potential must use adequate contraception.
- •No clinically apparent central nervous system metastases or carcinomatous meningitis.
- •No other active malignancy other than non-melanoma skin cancer or in-situ cervical carcinoma. A resected cancer (other than in-situ carcinoma) must have demonstrated no evidence of recurrence for at least 3 years.
- •Patients with history of severe hypersensitivity to irinotecan, cisplatin, taxotere or drugs formulated with polysorbate 80 must be excluded.
结局指标
主要结局
To assess the response rate of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan (CPT-11).
次要结局
- To assess the duration of response and overall survival of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan.
- To assess the toxicity of this combination in esophageal or gastric carcinoma.(4 years)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
1 期
Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor MalignanciesSolid TumorNCT00251407Dana-Farber Cancer Institute46
已完成
2 期
Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung CancerCarcinoma, Small Cell LungNCT00294931SCRI Development Innovations, LLC50
已完成
2 期
Irinotecan Study For Cervical CancerUterine Cervical NeoplasmsNCT00136955Pfizer41
Unknown
1 期
A Study of TS-1 Plus Irinotecan and Cisplatin (IP) for Patients With Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)Advanced Non-Small Cell Lung CancerNCT00874328National Cancer Center, Korea74
已完成
2 期
Trifluridine/Tipiracil and Irinotecan for the Treatment of Advanced Refractory Biliary Tract CancerAdvanced Bile Duct CarcinomaAdvanced Gallbladder CarcinomaRefractory Bile Duct CarcinomaRefractory Gallbladder CarcinomaStage III Distal Bile Duct Cancer AJCC v8Stage III Gallbladder Cancer AJCC v8Stage III Intrahepatic Bile Duct Cancer AJCC v8Stage IIIA Distal Bile Duct Cancer AJCC v8Stage IIIA Gallbladder Cancer AJCC v8Stage IIIA Intrahepatic Bile Duct Cancer AJCC v8Stage IIIB Distal Bile Duct Cancer AJCC v8Stage IIIB Gallbladder Cancer AJCC v8Stage IIIB Intrahepatic Bile Duct Cancer AJCC v8Stage IV Distal Bile Duct Cancer AJCC v8Stage IV Gallbladder Cancer AJCC v8Stage IV Intrahepatic Bile Duct Cancer AJCC v8Stage IVA Gallbladder Cancer AJCC v8Stage IVB Gallbladder Cancer AJCC v8NCT04072445Mayo Clinic28