Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality.
研究概览
简要总结
Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. The three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid, three times per week for 8 weeks. Subjects will also have co-administration of the chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9 to 18 participants will be enrolled in this Phase I study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic pancreatic cancer
- •Glucose 6 phosphate dehydrogenase status normal
- •ECOG performance status 0-2
- •Normal creatinine and transaminase
- •Women of child-bearing potential confirm negative pregnancy test
排除标准
- •Concurrent chemotherapy or radiotherapy
- •Significant co-morbid disorders
- •Significant psychiatric symptoms
- •Prior treatment with gemcitabine
- •Concurrent chronic use of immunosuppressive agents (methotrexate, cyclosporine,corticosteroids)
- •Regular use of nonsteroidal anti-inflammatory agents
- •Smoking more than 1 pack per day
- •Excessive alcohol or drug use
- •Enrollment in other experimental therapy
- •Active infection
- •Patients experiencing ongoing response to recent treatments
研究组 & 干预措施
Intravenous Vitamin C
干预措施: Gemcitabine and Erlotinib (Drug)
Intravenous Vitamin C
干预措施: Intravenous Vitamin C (Dietary Supplement)
结局指标
主要结局
Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality.
时间窗: 8 weeks
次要结局
- Progression-free survival(8 weeks)