Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Effect of nab-paclitaxel on pancreatic cancer stroma, new vessel formation and tumor cell metabolism.
研究概览
简要总结
Targeting tumor stroma is emerging as a strategic approach for pancreatic cancer treatment. Actually, one of the most interesting characteristics of pancreatic cancer is the dense fibrotic stroma surrounding tumor cells. Moreover, pancreatic cancer stroma seems to express a specific protein profile different from tumor cells. For example, secreted protein rich in cysteine (SPARC) is overexpressed in pancreatic tumor stroma fibroblast and downregulated in tumor cells. This characteristic is associated with poor clinical outcome.
Nab-paclitaxel, an albumin bound nano formulation of paclitaxel that targets SPARC, decreases tumor stroma density. Such effect improves drug delivery, and enhances both, nab-paclitaxel and gemcitabine, antitumor activity in nude mouse models.
Based on this pre-clinical data the investigators designed a clinical trial of nab-paclitaxel in combination with gemcitabine as neo-adjuvant treatment for pancreatic cancer patients. Fifteen, SPARC positive patients, will be enrolled in the study and treated with abraxane in combination with gemcitabine.
This is a pilot study which primary end point is evaluating the effect of Abraxane in combination with gemcitabine on tumor stroma, and the secondary end-point is correlating these changing with treatment activity.
详细描述
Study Phase: Pilot study to assess nab-paclitaxel in combination with gemcitabine effects on pancreatic cancer stroma and tumor metabolism.
Study Objective(s):
A) Primary end-points:
- Evaluate the effect of nab-paclitaxel in combination with gemcitabine on tumor stroma density.
- Evaluate the effect of nab-paclitaxel on tumor vessels formation.
- Evaluate the effect of nab-paclitaxel on tumor metabolism.
B) Secondary end-point:
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
- •Patients who are 18 years or older;
- •Patients with resectable/resectable borderline pancreatic cancer;
- •Adequate hematopoietic, hepatic and renal function:
- •Neutrophil count > o = 1.5 x 109/L;
- •Platelet count > o = 100 x 109/L;
- •Bilirubin ≤ 1.5 x ULN;
- •AST and/or ALT ≤ 2.5 x ULN;
- •Serum creatinine ≤ 1.5 x ULN.
- •Investigators must ensure that patients enrolled in the study will be available for all study procedures, including tumor biopsy, surgical treatment, and follow up.
- •Investigators must ensure that patients have the ability to understand the requirements of the study and provide signed informed consent.
- •Signed Informed Consent.
排除标准
- •Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with patient eligibility for treatment;
- •History of any psychiatric condition that might impair patient's ability to understand or to comply with the requirements of the study or to provide informed consent;
- •Concurrent anticancer therapy;
- •Pregnant or breast-feeding women (documented methods of birth control are required in those with reproductive potential);
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs;
- •History of life threatening reaction to gemcitabine or abraxane;
- •Previous exposure to other agents or treatment procedure as radiotherapy for the treatment of pancreatic cancer.
研究组 & 干预措施
Gemcitabine plus nab-paclitaxel
This is a single arm study.
干预措施: Gemcitabine plus nab-paclitaxel (Drug)
结局指标
主要结局
Effect of nab-paclitaxel on pancreatic cancer stroma, new vessel formation and tumor cell metabolism.
时间窗: up to 18 months
Primary End-point: 1. Evaluate the effect of nab-paclitaxel in combination with gemcitabine on tumor stroma density. 2. Evaluate the effect of nab-paclitaxel on tumor vessels formation. 3. Evaluate the effect of nab-paclitaxel on tumor metabolism by PET-CT scan measuring pre-treatment versus post-treatment glucose uptake.
次要结局
- Activity of nab-paclitaxel in combination with gemcitabine against PDA in relation with changes in tumor stroma and tumor metabolic activity.(up to 18 months)
研究者
Sofia Perea, Director Clinical Trials Unit.
Director Clinical Research Unit
Grupo Hospital de Madrid