NCT00044785终止1 期
A Phase I Study of Escalating Doses of CPT-11 and 5fluorouracil (5FU) Plus PN401 With a Fixed Dose of Leucovorin in Patients With Solid Tumor Malignancies.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety and Maximum Tolerated Dose
研究概览
简要总结
CPT-11 and 5Fluorouracil (5FU) combined with leucovorin has become the standard of care for colorectal cancer. PN401 permits treatment with higher than normal doses of 5FU, which could increase its therapeutic potential. It is hypothesized that adding PN401 to the CPT-11, 5FU, leucovorin regimen will reduce toxicity and will allow higher doses of 5FU to be well tolerated and therefore potentially increase effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Must be at least 18 years of age;
- •Life expectancy: At least 3 months;
- •Performance status: ECOG of 0 or 1;
- •Histologic or cytologic proof of a solid tumor cancer that is not amenable to curative surgical resection;
- •Evaluable or measurable disease documented within 4 weeks of the start of treatment;
- •Prior chemotherapy or radiotherapy is allowed if 4 weeks or more have elapsed prior to starting treatment and patients have recovered from toxicities of prior treatment;
- •Adequate organ function:
- •Hematopoietic: ANC = 1500/ul or more, Platelets = 100,000/ul or more, Hemoglobin = 9.5 g/dL or more, transfusion prior to evaluation is allowed; Hepatic: Bilirubin = 2.0 mg/dL or less and SGPT(ALT) and SGOT(AST) < 3 x upper limit of normal (< 5 x upper limit of normal if liver metastases present) Renal: Serum Creatinine < 2.0 mg/dL;
- •Patient has the initiative, geographic proximity, and means to be compliant with the protocol;
- •Fertile patients (male or female) must agree to use effective contraception;
- •Must be able to swallow and retain tablets.
排除标准
- •Major surgery within the four weeks preceding the start of treatment;
- •Serious medical or psychiatric illness that would prevent self-determined informed consent;
- •Intensive chemotherapy treatment;
- •Infection or antibiotics at the time of screening;
- •Uncontrolled cardiovascular, pulmonary, renal, neurologic, psychiatric, or hepatic dysfunction;
- •Pregnant or nursing;
- •Pre-existing diarrhea or uncontrolled clinically significant illness other than cancer (i.e. ulcerative colitis, malabsorption syndrome);
- •Brain metastases that have not been stable for more than 3 months;
- •Known Dihydropyrimidine Dehydrogenase (DPD) deficiency.
结局指标
主要结局
Safety and Maximum Tolerated Dose
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT04742101Institut de Recherches Internationales Servier57
已完成
1 期
First Time in Human Study of ProtexiaIntervention for Nerve Agent ExposureNCT00744146PharmAthene, Inc.33
撤回
1 期
A Study of Toca 511 & Toca FC in Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer (Toca 8)Bladder CancerNCT04089163Tocagen Inc.
终止
1 期
This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT00932126Pfizer35
已完成
1 期
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular DegenerationAge-Related Macular DegenerationNCT02555306Santen Inc.12