A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy
试验速览
- 阶段
- 2 期
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Tumor response
研究概览
简要总结
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hyperthermia may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil and liposomal doxorubicin together with systemic hyperthermia works in treating patients with metastatic breast, ovarian, endometrial, or cervical cancer.
详细描述
OBJECTIVES:
- Evaluate tumor response and toxicity induced by fluorouracil and doxorubicin HCl liposome combined with mild systemic hyperthermia in patients with metastatic breast, ovarian, endometrial, or cervical cancer.
OUTLINE: This is a time-escalation study of systemic hyperthermia.
Patients receive fluorouracil IV continuously over 24 hours on days 1-5 and doxorubicin HCl liposome IV over 30 minutes on day 6. Beginning on day 7, patients receive heat applied for 6-24 hours (in 6-hour sequential treatments) using a mild hyperthermia-induction device. Treatment repeats every 4-5 weeks for a total of 4 courses. Patients who achieve less than a complete response but have no disease progression may receive additional courses of chemotherapy alone.
Cohorts of 5 patients receive escalating durations of hyperthermia until the recommended phase II duration is determined. The recommended phase II duration of hyperthermia is defined as the level preceding that at which 1 of 5 patients experiences measurable toxicity. (Phase I closed as of 9/28/01)
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
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic breast, ovarian, endometrial, or cervical carcinoma
- •Measurable and evaluable disease
- •No brain metastases
- •No hepatic involvement greater than 80%
- •No lung involvement greater than 30%
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Not specified
- •Menopausal status:
- •Not specified
- •Performance status:
- •Zubrod 0-2
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute granulocyte count greater than 1,500/mm^3
- •Platelet count greater than 90,000/mm^3
- •Normal bone marrow cellularity on bone marrow biopsy
- •Thrombin time less than 17 sec
- •Fibrinogen greater than 200 mg/dL
- •FSP less than 40
- •No coagulopathy
- •Bilirubin less than 2.0 mg/dL
- •SGPT less than 2 times normal
- •PT less than 14 sec
- •PTT less than 35 sec
- •BUN less than 25 mg/dL
- •Creatinine clearance at least 45 mL/min
- •Cardiovascular:
- •Normal cardiovascular system
- •Resting ventricular ejection fraction greater than 40%
- •No prior myocardial infarction
- •No symptomatic coronary artery disease
- •No unstable blood pressure
- •No thromboembolic disease
- •Neurologic:
- •No seizures or other CNS disorders
- •Negative computerized tomographic scan of brain
- •FEV_1 greater than 70% of predicted
- •Arterial pressure of oxygen greater than 60 mmHg on room air with appropriate pressure of carbon dioxide and pH values
- •No history of cardiopulmonary or respiratory disease
- •No other serious concurrent medical illness
- •No diabetes mellitus
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- 另有 8 项未显示
排除标准
- 未提供
结局指标
主要结局
Tumor response
Toxicity
次要结局
未报告次要终点