Ph 2 Trial of G-FLIP (Low Doses Gemcitabine, 5FU, Leucovorin, Irinotecan & Oxaliplatin), Followed by G-FLIP-DM (G-FLIP + Low Doses Docetaxel & MitomycinC), When Used in Combination With Vitamin C, in Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
Pancreatic cancer, especially at advanced metastatic stage, is a devastating disease. It is the fourth leading cause of cancer death. Its prognosis is grim - 5-year survival rate being 6%. The current therapies for advanced metastatic pancreatic cancer are very toxic and with limited efficacy. A safer and more effective therapy for this devastating disease is greatly needed.
G-FLIP regimen is a combination of low doses (doses lower than those approved by the FDA and used in the clinic) of several anti-cancer drugs, Gemcitabine, Fluorouracil, Leucovorin, Irinotecan and Oxaliplatin. The efficacy of G-FLIP against cancers (especially pancreatic cancer) is based on laboratory and clinical results, which indicates the synergistic efficacy of these anti-cancer drugs against cancer cells and overcoming tumor drug resistance that cancer cells frequently develop. Also, because of their low doses, this regimen is less toxic than when these drugs are used alone.
Meanwhile, intravenous infusion of high doses (doses significantly higher than the daily nutritional requirements) of Vitamin C (ascorbic acid) has been observed to have anti-cancer activities. This is especially true when Vitamin C is used in combination with other anti-cancer drugs.
详细描述
STUDY OBJECTIVE
The objective of this study is to evaluate the safety, tolerability and efficacy of G-FLIP (Low Doses of Gemcitabine, Fluorouracil [5FU], Leucovorin, Irinotecan, and Oxaliplatin), when used in combination with ascorbic acid (Vitamin C), as first-line therapy in patients with advanced pancreatic cancer. The objective of this study is also to evaluate the safety, tolerability and efficacy of G-FLIP-DM (G-FLIP + Low Doses of Docetaxel and Mitomycin C), when used in combination with ascorbic acid, in patients with advanced pancreatic cancer who develop Disease Progression (DP) with G-FLIP treatment. The primary endpoint is 12-month survival rate. The secondary endpoints include Overall Survival (OS), Quality of Life (QOL), Response Rate (RR), Progression-Free-Survival (PFS), and safety.
STUDY DRUGS
Study drugs include G-FLIP, G-FLIP-DM, and Vitamin C (Ascorbic Acid)
STUDY DESIGN
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients must have histologically and cytologically confirmed metastatic (Stage IV), locally advanced unresectable (stage III), or locally recurrent pancreatic adenocarcinoma, with or without prior chemotherapy for their cancer.
- •Eastern Cooperative Oncology Group (ECOG) performance status being 0-
- •Expected survival >3 months.
- •Patients 18 years of age and older of both genders.
- •Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 2 weeks prior to treatment initiation.
- •Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
- •At least 2 weeks must have elapsed from any prior surgery or hormonal therapy.
- •Laboratory values ≤2 weeks must be:
- •Adequate hematologic
- •Adequate hepatic function
- •Adequate renal function
- •No evidence of active infection and no serious infections within the past month.
- •Mentally competent, able to understand and willing to sign the informed consent form.
排除标准
- •Patients under the age of
- •Locally advanced resectable disease from pancreatic cancer
- •Previous radiotherapy for cerebral metastases, central nervous system (CNS) or epidural tumor.
- •Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any non-cancer indication within the past 4 weeks.
- •Patients with any active uncontrolled bleeding, or a bleeding diathesis.
- •Pregnant women, or women of child-bearing potential not using reliable means of contraception.
- •Lactating females.
- •Fertile men unwilling to practice contraceptive methods during the study period.
- •Life expectancy less than 3 months.
- •Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients.
- •Unwilling or unable to follow protocol requirements.
- •Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction, or symptomatic congestive heart failure.
- •Patients with a history of myocardial infarction that is < 3 months prior to registration.
- •Patients with any amount of clinically significant pericardial effusion.
- •Evidence of active serious infection.
- •Patients with known HIV infection.
- •Requirement for immediate palliative treatment of any kind including surgery and radiation.
- •Patients that have received a chemotherapy regimen requiring stem cell support in the previous 6 months.
- •Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient.
研究组 & 干预措施
G-FLIP+VitaminC, then G-FLIP-DM+VitaminC
G-FLIP in combination with Vitamin C, then G-FLIP-DM in combination with Vitamin C
干预措施: G-FLIP (Drug)
G-FLIP+VitaminC, then G-FLIP-DM+VitaminC
G-FLIP in combination with Vitamin C, then G-FLIP-DM in combination with Vitamin C
干预措施: G-FLIP-DM (Drug)
G-FLIP+VitaminC, then G-FLIP-DM+VitaminC
G-FLIP in combination with Vitamin C, then G-FLIP-DM in combination with Vitamin C
干预措施: Vitamin C (Dietary Supplement)
G-FLIP, then G-FLIP-DM
G-FLIP alone, then G-GLIP-DM alone
干预措施: G-FLIP (Drug)
G-FLIP, then G-FLIP-DM
G-FLIP alone, then G-GLIP-DM alone
干预措施: G-FLIP-DM (Drug)
结局指标
主要结局
Overall Survival
时间窗: Survival was monitored from the first day of treatment until the date of death or last followed up.
Mean months subjects survived.
次要结局
- Objective Response(Performed before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years after the start of treatment.)