NCT01049880已完成1 期
A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer
Joseph J. Cullen1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine)
研究概览
简要总结
This study is designed to determine the maximum tolerated dose of vitamin C when given with a standard chemotherapy for people who have metastatic pancreatic cancer.
详细描述
This is a phase I, dose-escalating study of ascorbic acid (vitamin C) designed to determine the maximum tolerated dose of vitamin C or, if well tolerated, the dose required to obtain a desired ascorbic acid plasma concentration.
Because this is a phase I study, prospective subjects should have advanced disease (i.e., metastasis) and have failed other curative therapies (or, are unable to receive curative therapies due to comorbidities or stage of disease).
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
- •Normal G6PD status
- •Histologically or cytologically diagnosed pancreatic adenocarcinoma.
- •Disease extent documented by CT scan (radiologically measurable disease is not required)
- •Ambulatory patient without evidence of spinal cord compression
- •No prior chemotherapy for metastatic disease
- •Failed curative therapy or patient ineligible for definitive curative therapy
- •Completed adjuvant therapy at least 4 weeks prior and recovered from any/all toxicities related to that treatment.
- •If post-therapy, must have disease progression since that treatment
- •If treated with prior radiation therapy, disease must be outside of the radiation fields
- •No currently active second malignancies unless it is a non-melanoma skin cancer
- •Women must be non-pregnant and non-lactating
- •ECOG performance of 0, 1, or 2
- •Granulocytes at least 1,500 / ul
- •Platelets at least 100,000 / ul
- •Creatinine less than 1.5 mg/dL or clearance of at least 60 mL / min
- •Total bilirubin less than 2 times the upper limit of normal
- •AST and ALT less than 3 times the upper limit of normal if liver metastases are not present. If liver metastases are present, AST and ALT less than 5 times the upper limit of normal
- •PT INR less than 1.5 (unless the patient is on full dose warfarin)
- •Patient must be at least 18 years of age
- •Patient must be able to understand consent process, the research study, and be able to sign the consent document
排除标准
- •A psychiatric disorder by history or examination that would prevent completion of the study
- •ECOG performance of 3 or 4
- •Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.
- •Consumption of excess alcohol (more than 4 drinks per day) or use of illicit drugs
- •Continued sse of over-the-counter antioxidants (supplements like vitamin C and grape seeds)
研究组 & 干预措施
Ascorbate
Experimental
干预措施: Gemcitabine with escalating ascorbic acid (Drug)
结局指标
主要结局
Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine)
时间窗: weekly
次要结局
- Survival(Ongoing)
- Plasma ascorbate level (targeted to 350 to 400 mg/dL)(Weekly)
研究者
Joseph J. Cullen
Professor
University of Iowa
研究点 (1)
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