NCT00809796已完成1 期
A Phase I/II Clinical Study Using Pentamidine in Patients With Metastatic Colon Cancer Undergoing Standard Folinic Acid, 5-Fluorouracil, or Capecitabine and Oxaliplatin Chemotherapy as Second-line and/or Third-line Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Any severe events, tumor marker CEA, and tumor size (CT scan)
研究概览
简要总结
The purpose of this study is to investigate the safety and possible efficacy of the use of pentamidine in the treatment of colon cancer metastasis in subjects receiving standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 or cytologically proven diagnosis of adenocarcinoma of the colon or rectum with evidence of (1) unresectable, locally recurrent, or (2) metastatic disease
- •Failure of first-line or second-line therapy for colorectal cancer
- •At least one unidimensional measurable lesion (on spiral CT scan)
- •18 years of age or older
- •ECOG performance status 0, 1 or 2
- •Serum aspartate transaminase (AST) serum alanine transaminase (ALT) £ 2.5 x upper limit of normal (ULN), or AST and ALT £ 5 x ULN if liver function abnormalities are due to underlying malignancy
- •Total serum bilirubin £ 1.5 x ULN
- •Serum albumin ≥ 3.0 g/dL
- •lipase within normal limits
- •Absolute neutrophil count (ANC) ≥ 1500/uL (1.5 x 109/L)
- •Platelets ≥ 100,000/uL
- •Hemoglobin ≥ 9.0 g/dL
- •Serum creatinine £ 1.5 x ULN or calculated creatinine clearance ≥ 50 ml/min
- •Magnesium ≥ lower limit of normal
- •CEA level ≥ 3.4 ng/ml
- •Normal ECG
- •Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures
- •Life expectancy, in the opinion of the investigator, > 3 months
排除标准
- •BP < 100 (systolic)
- •History of renal disease, pancreatitis, or diabetes mellitus
- •Peripheral sensory neuropathy (> Grade 1, as per NCI CTCAE version 3.0)
- •Concomitant therapy with other investigational agents or participation in another clinical trial
- •Any of the following conditions: Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2; atrial fibrillation of any grade; QTc interval >450 msec for males or >470 msec for females or uncontrolled intercurrent illness, e.g., unstable angina; severe coronary disease, ventricular arrhythmias, bradycardia <50 bpm
- •Active uncontrolled bacterial infection
- •Concurrent use of drugs that could prolong QT interval
- •Concurrent use of nephrotoxic drugs, including aminoglycosides, ampho B, foscarnet, cidofovir
- •Concurrent use of drugs that may be associated with pancreatitis
- •Concurrent active cancer originating from a primary site other than colon/rectum, except for surgically treated nonmelanoma skin cancer, in situ cervical cancer, or localized prostate cancer with undetectable PSA level
- •Co-existing lung disease
- •History of allergy or hypersensitivity to pentamidine Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to first dose of study medication.
- •Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgement of the investigator, excess risk associated with trial participation of study drug administration, or which in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
- •On oral anticoagulants
研究组 & 干预措施
single arm
Experimental
Use of pentamidine in second and/or third line metastatic colon cancer
干预措施: pentamidine (Drug)
结局指标
主要结局
Any severe events, tumor marker CEA, and tumor size (CT scan)
时间窗: Three Months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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