A Randomized, Placebo-controlled, Blinded Phase II Study of Huachansu & Gemcitabine in Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Progression Free Survival at 4 Months
研究概览
简要总结
This protocol is part of a larger grant funded by the NCI to create an international research center to study traditional Chinese medicine (TCM). All of the patients enrolled in this study will be treated at the Cancer Hospital, Fudan University, our sister institution in Shanghai, China. No patients will be seen at MDACC. This protocol will be overseen by the Fudan University Institutional Review Board (IRB00002408) which has Federal Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25, 2002). The research nurses have received training at MDACC and will receive regular oversight by MDACC personnel.
Primary End Point:
- Determine the efficacy of huachansu as measured by progression free survival at 4 months.
Secondary End Points:
- Examine the feasibility and safety of treatment using huachansu in combination with gemcitabine in patients with pancreatic cancer.
- Determine clinical efficacy by other measures including tumor response, 6-month survival, and changes in quality of life (QOL) in patients with pancreatic cancer.
- Monitor patient blood levels of the three main cardiac glycosides that are in huachansu (bufalin, cinobufagin, and resibufogenin). This information will provide evidence to delineate the role of these cardiac glycosides in antitumor activity.
详细描述
The Study Drugs:
HuaChanSu is a substance used in China to treat different types of cancer. One of the major elements of the substance is bufalin, which is an ingredient that has been shown to block the growth of tumor cells.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Screening:
Before you can receive study treatment, you will have "screening tests." These tests will help the study doctor decide if you are eligible to take part in this study. The following tests will be performed:
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
- Double (Participant, Investigator)
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
- •Histologically/cytologically confirmed unresectable (locally advanced or stage IV) pancreatic adenocarcinoma.
- •Karnofsky Performance Status > 60 (see Appendix H for definition)
- •Measurable disease by RECIST criteria must be present. Bone scan abnormalities alone will not be accepted as measurable disease. Lytic lesions seen on plain radiographs will not be accepted as measurable disease but will be evaluated in conjunction with bone scan abnormalities. Pure blastic bone metastases will not be accepted as measurable disease. Pleural or peritoneal effusions will not be accepted as measurable disease. Irradiated lesions are not considered measurable.
- •Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
- •Patients must have adequate organ functions reflected by the laboratory criteria below: Granulocytes >1,500/uL; Hemoglobin >/= 8.0 gm/dL; Platelets > 100,000/uL; Serum creatinine < 2.0 mg/dL; Bilirubin < 1.5 mg/dL; SGPT < 3 x normal; Alk Phos < 3 x normal; Calcium </=11.0 mg/dL
- •Patients must not have received any prior chemotherapy. Prior exposure to Traditional Chinese Medicine is allowed provided that at least one week washout time is given prior to initiation of experimental treatment.
- •Concomitant bisphosphonates are allowed for patients with bone metastases.
- •Patients with jaundice must have a biliary drainage decompression operation before recruitment.
- •Ability to understand and the willingness to sign a written informed consent.
- •Prior local therapy, e.g., TACE or radiation, is allowed provided that at least 4 weeks washout time is given.
排除标准
- •Known central nervous system involvement and leptomeningeal disease
- •Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.
- •Known allergies to the huachansu or toad skin products.
- •Concurrent infection requiring intravenous antibiotics.
- •Pregnant or lactating women.
- •Prior treatment with systemic chemotherapy.
研究组 & 干预措施
Gemcitabine + HuaChanSu
Gemcitabine 1,000 mg/m2 once a week for 3 weeks then 1 week off + HuaChanSu 20 mL/m2 for total 500 mL given as a 2 hour infusion, 5 days a week for 3 weeks then one week off (28 Day Cycle).
干预措施: Gemcitabine (Drug)
Gemcitabine + HuaChanSu
Gemcitabine 1,000 mg/m2 once a week for 3 weeks then 1 week off + HuaChanSu 20 mL/m2 for total 500 mL given as a 2 hour infusion, 5 days a week for 3 weeks then one week off (28 Day Cycle).
干预措施: HuaChanSu (Drug)
Gemcitabine + Placebo
Gemcitabine 1,000 mg/m2 once a week for 3 weeks then 1 week off (28 Day Cycle) + Placebo 500 ml saline only administered as a 2 hour infusion by central line.
干预措施: Gemcitabine (Drug)
Gemcitabine + Placebo
Gemcitabine 1,000 mg/m2 once a week for 3 weeks then 1 week off (28 Day Cycle) + Placebo 500 ml saline only administered as a 2 hour infusion by central line.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression Free Survival at 4 Months
时间窗: 4 Months
Number of participants without disease progression four months following treatment.
次要结局
- Median Overall Survival(Up to 4 Years)