Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma
试验速览
- 阶段
- 2 期
- 发起方
- 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. Giving the drugs directly into the tumor after surgery and combining them with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy, and radiation therapy in treating patients who have peritoneal cancer.
详细描述
OBJECTIVES:
- Determine the response rate, duration of response, and duration of survival of patients with peritoneal mesothelioma treated with surgery, intraperitoneal chemotherapy, and whole abdominal radiotherapy.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients undergo initial surgery, including total omentectomy and excision of gross disease. Approximately 3-4 weeks after surgery, patients receive intraperitoneal (IP) chemotherapy consisting of doxorubicin IP over 2 hours once weekly on weeks 1, 4, 7, and 10 and cisplatin IP and gemcitabine IP once weekly on weeks 2, 5, 8, and 11. Patients also receive interferon gamma IP once weekly on weeks 13-16.
At approximately week 18-20, patients undergo second-look surgery. Patients with no gross disease receive hyperthermia mitomycin IP and cisplatin IP over 90 minutes.
Approximately 2-4 weeks after second-look surgery, patients undergo radiotherapy 5 days a week for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
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 malignant mesothelioma
- •Measurable or evaluable disease
- •Ineligible for other high-priority study
- •No CNS metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 2 months
- •Hematopoietic:
- •WBC greater than 3,000/mm3
- •Platelet count greater than 100,000/mm3
- •Bilirubin less than 1.5 times normal
- •Creatinine clearance at least 45 mL/min
- •BUN less than 1.5 times normal
- •No significant calcium abnormalities
- •Cardiovascular:
- •No symptomatic cardiovascular disease
- •No New York Heart Association class II, III, or IV heart disease
- •No congestive heart failure
- •No angina pectoris
- •No cardiac arrhythmia
- •No uncontrolled hypertension
- •No significant phosphate, electrolyte, or other metabolic abnormalities (e.g., metabolic acidosis)
- •No uncontrolled psychiatric disorder or neurologic disease
- •No seizure disorder
- •No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or skin cancer
- •No other serious medical or psychiatric illness
- •No uncontrolled serious infection
- •No senility or emotional instability
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No more than 2 prior chemotherapy regimens
- •No more than 1 prior intraperitoneal chemotherapy regimen
- •More than 6 weeks since prior chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes)
- •Concurrent steroids for antiemesis, premedication, adrenal failure, or septic shock allowed
- •Radiotherapy:
- •No prior abdominal, pelvic, or lower chest radiotherapy
- •Prior surgical resection preceding disease recurrence allowed
- •More than 1 week since prior surgery
排除标准
- 未提供