Phase I Trial of Combined Modality Irinotecan, Cisplatin, and Concurrent Radiation Therapy for Patients With Locally Advanced Esophageal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have advanced cancer of the esophagus.
详细描述
OBJECTIVES:
- Determine the dose limiting toxicity of irinotecan when given weekly with cisplatin and concurrent external beam multifield radiotherapy in patients with locally advanced carcinoma of the esophagus or gastroesophageal junction.
- Determine the maximum tolerated dose and the recommended phase II dose of irinotecan in this regimen in this patient population.
- Evaluate the complete response rate in these patients to one course of induction chemotherapy followed by concurrent chemotherapy and radiotherapy.
OUTLINE: This is a dose escalation study of irinotecan.
Patients receive induction chemotherapy with cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 15, and 22. Following 2 weeks of rest, patients begin chemoradiation. Patients receive cisplatin and irinotecan as above on days 1, 8, 22, and 29 and radiotherapy once daily 5 days a week for 5-6 weeks.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
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 or gastroesophageal junction
- •T1, N1, M0 or T2-4, Nx, M0
- •No supraclavicular or celiac lymph nodes
- •Previously untreated, newly diagnosed tumors OR
- •Prior resection without adjuvant therapy with local regional failure
- •Positive microscopic margin on resection of all gross disease allowed provided no metastatic disease
- •No positive malignant cytology of the pleura, pericardium, or peritoneum
- •No biopsy proven tumor invasion of the tracheobronchial tree or tracheoesophageal fistula
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100% OR
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9.0 g/dL
- •Bilirubin no greater than 1.5 mg/dL
- •No known Gilbert's disease
- •Creatinine no greater than 1.5 mg/dL
- •No hypercalcemia
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •No myocardial infarction within the past 6 months
- •No uncontrolled hypertension
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other severe concurrent conditions (e.g., severe uncontrolled diabetes, uncontrolled infections, or cerebral vascular disease)
- •No other malignancy within the past 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •No history of seizure disorder currently receiving phenytoin, phenobarbital, or other antiepileptic medication
- •No other concurrent medical or psychiatric condition or disease that would preclude study entry
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy for esophageal cancer including adjuvant chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy for esophageal cancer including adjuvant radiotherapy
- •No prior mantle, chest, pelvic, or hemibody radiotherapy
- •See Disease Characteristics
- •No concurrent prochlorperazine on day of irinotecan administration
排除标准
- 未提供