EUCTR2004-005215-29-GB进行中（未招募）1 期
A Multi-Center, Open Label, Parallel Group, Randomised, Phase IIB Clinical Trial to Evaluate the Safety and Efficacy of CoFactor and 5-FU versus Leucovorin and 5-FU in Subjects with Metastatic Colorectal Carcinoma
ADVENTRX Pharmaceuticals Inc0 个研究点目标入组 300 人开始时间: 2005年2月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Male or a non-pregnant, non-lactating female subjects. = 18 years of age.
- •Surgically incurable, confirmed metastatic colon or rectal adenocarcinoma.
- •Have measurable disease for response assessment. At least one measurable lesion with a diameter = 20 mm using conventional CT or MRI scans or = 10 mm using spiral CT scans (use of spiral must be documented in medical records and used consistently throughout the study). Ascites or pleural effusion(s) are not acceptable as single sites of response assessment, but be present if measurable disease is present for evaluation.
- •Have a ECOG Performance level of 1-2 (or Karnofsky 100-70). A lower ECOG Performance level is acceptable only if clearly due to non-oncologic problems (e.g., prior paraplegia from polio).
- •Have a life expectancy of a least 6 months.
- •Have recovered from any toxicities resulting from prior therapies (patients with alopecia will not be excluded).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Failure by the subject or the subject’s legal representative to sign the Informed Consent.
- •An inability to obtain Informed Consent because of psychiatric or complex medical problems.
- •Concurrent infection including diagnoses of FUO and evidence of possible central line sepsis (subject must be afebrile at the start of therapy).
- •Unstable oncologic emergency syndromes superior vena cava (SVC) syndromes, rising bilirubin needing stent placement, spinal cord compression, progressive brain metastases, active bleeding, hypercalcemia, etc.
- •Unstable medical conditions such as acute coronary syndrome, cardio-vascular accident within the previous 12 months (such as transient ischemic attacks, accelerated hypertension), etc.
- •Cerebellar neurologic syndromes such as Parkinson’s disease, multiple sclerosis, and amyotonia.
- •Have received prior chemotherapy for established metastatic disease.
- •A known intolerance to fluoropyrimidine (5-FU, Capecitabine, Floxuridine, UFT) therapy (dihydropyrimidine dehydrogenase) deficiency.
- •Less than 8-weeks since radiation therapy or less than 4 weeks since major surgery.
- •Less than 6 months since prior adjuvant 5-FU or CPT-11 therapy, or Mitomycin C or nitrosourea therapy.
- •Patients with vomiting, diarrhea, nausea of Grade greater than 1.
- •Females of childbearing potential who do not agree to use adequate contraception throughout their participation in this study and for 30 days after discontinuation of study medication. (Women of childbearing potential must have a negative pregnancy test prior to the start of the study.)
- •Have laboratory results of –
- •Serum creatinine greater than 1.5 times the upper limit of normal
- •Serum bilirubin greater than 2 times the upper limit of normal
- •ANC <1.5 x 10*9/L
- •Platelet count <90 x 10*9/L
- •SGOT (AST) and SGPT (ALT) greater than 3 times the upper limit of normal.
- •Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug.
研究者
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