NCT00082862Unknown2 期
A Phase II Clinical Trial of a Timing/Schedule Optimized Combined-Modality Regimen: Cisplatin + Metronomic Low-Dose Interferon-α (IFN-α) Followed by Gemcitabine HCl (GEMZAR) in Combination With Mild, Fever-Range Whole-Body Hyperthermia (FR-WBH) in Patients With Advanced, Inoperable Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Tumor response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving low-dose interferon alfa on a metronomic (regularly timed) schedule may stop the growth of cancer by stopping blood flow to the tumor. Fever-range (above 101° F) whole-body hyperthermia kills tumor cells by heating them to several degrees above normal body temperature. Combining cisplatin, gemcitabine, and low-dose interferon alfa with fever-range whole-body hyperthermia may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin, gemcitabine, and metronomic low-dose interferon alfa together with fever-range whole-body hyperthermia works in treating patients with inoperable or metastatic pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine tumor response in patients with inoperable or metastatic pancreatic cancer treated with cisplatin, metronomic low-dose interferon alfa, gemcitabine, and fever-range whole-body hyperthermia.
- Determine the toxicity of this regimen in these patients.
- Determine the survival of patients treated with this regimen.
- Determine changes in quality of life in patients treated with this regimen.
Secondary
- Determine whether inoperable tumors convert to operable in patients treated with this regimen.
- Determine changes in cellular and cytokine immune function in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed pancreatic carcinoma
- •Inoperable or metastatic disease
- •Measurable lesion by physical examination, CT scan, or MRI
- •Carcinomatous hepatomegaly is considered measurable if a palpable liver edge clearly extends > 15 cm below the costal margin or xiphoid process
- •No known brain metastases by CT scan or MRI
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Hemoglobin > 10.0 g/dL
- •Platelet count ≥ 90,000/mm^3
- •Bone marrow cellularity normal on bone marrow biopsy
- •No serious coagulopathy disorder
- •Bilirubin ≤ 2.5 mg/dL
- •SGPT and SGOT ≤ 2 times upper limit of normal
- •PT < 14 seconds
- •PTT < 35 seconds
- •INR < 1.5
- •Creatinine ≤ 1.8 mg/dL
- •Creatinine clearance ≥ 45 mL/min
- •Blood urea nitrogen ≤ 25 mg/dL
- •Cardiovascular
- •Adequate cardiovascular function as documented by the following:
- •History and physical examination
- •Stress exercise test (MUGA or echocardiogram) with resting blood pressure, heart rate, and LVEF that increase appropriately with exercise
- •LVEF ≥ 45%
- •No myocardial infarction within the past 6 months
- •No symptomatic coronary artery disease
- •No angina
- •No unstable blood pressure
- •No congestive heart failure
- •No significant arrhythmia
- •No conduction disturbance
- •No thromboembolic disease
- •No uncontrolled hypertension
- •Complete pulmonary function studies with the following arterial blood gas values:
- •FEV_1 ≥ 70% of predicted
- •Arterial PO_2 ≥ 60 mm Hg on room air
- •PCO_2 appropriate
- •pH appropriate
- •No massive (≥ 30%) lung disease
- •DLCO > 50% of predicted
- •No prior or concurrent seizures or other CNS disorders
- •No prior malignant hyperthermia after general anesthesia
- 另有 21 项未显示
排除标准
- 未提供
结局指标
主要结局
Tumor response
Toxicity
Survival
Changes in quality of life
次要结局
- Conversion of inoperable tumors to operable
- Changes in cellular and cytokine immune function
研究者
研究点 (2)
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