NCT00691054已完成2 期
Phase II Trial of Abraxane® in the Treatment of Patients With Pancreatic Cancer Who Have Failed First-Line Treatment With Gemcitabine-Based Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Overall Survival Rate at 6 Months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with locally advanced or metastatic pancreatic cancer that did not respond to first-line therapy with gemcitabine.
详细描述
OBJECTIVES:
Primary
- To establish preliminary evidence of efficacy of paclitaxel albumin-stabilized nanoparticle formulation in patients with locally advanced (unresectable) or metastatic pancreatic cancer that failed first-line therapy with a gemcitabine hydrochloride-containing regimen.
Secondary
- To determine the safety and characterize the toxicity profile of this drug.
- To determine the complete, partial, and overall response rates and duration of response in patients with measurable disease.
- To determine CA 19-9 response.
- To determine progression-free survival.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed, locally advanced (unresectable) or metastatic pancreatic cancer, and have failed first-line treatment with a gemcitabine-containing regimen.
- •Patients have to be 18 years-old or older
- •Able to give signed Informed consent
- •Adequate end-organ function with laboratory parameters as follows:
- •Neutrophils: 1.5 x10^9/L or greater
- •Plts: 100 x10^9/L or greater
- •Hemoglobin: ≥ 9.0g/dL
- •Serum Creatinine: ≤ 1.5mg/dL
- •Bilirubin: ≤ 1.5 times the upper limit of the normal range (ULN)
- •Alanine transaminase (ALT)/Aspartate transaminase (AST): ≤ 2.5 times ULN
- •Adequate contraception: For female (or male) patients, either post-menopausal, or for pre-menopausal surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study
- •Measurable or non-measurable disease by RECIST criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- •Patients must be at least 3 weeks from prior therapies and must have recovered from prior toxicity
- •Life expectancy greater than 3 months
- •Willing and able to comply with the protocol requirement.
- •Patients must not have any peripheral neuropathy equal or greater than grade 2
排除标准
- •Chemotherapy within 3 weeks prior to enrollment
- •Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.
- •Any major surgery within 4 weeks prior to enrollment
- •Peripheral neuropathy equal to or greater than grade 2
- •Clinical AIDS or known positive HIV serology
- •Evidence of concurrent, clinically evident malignancy, except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years
- •Unstable angina
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •History of myocardial infarction within 3 months
- •History of stroke within 3 months
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study
- •Pregnant (positive pregnancy test) or lactating
- •Inability to comply with study and/or follow-up procedures
- •Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.
- •Participants cannot have been in another experimental drug study within 4 weeks of the first infusion of these study medications.
研究组 & 干预措施
Abraxane
Experimental
One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4.
干预措施: Abraxane (Drug)
结局指标
主要结局
Overall Survival Rate at 6 Months
时间窗: 6 months
Overall survival was measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. For patients who are alive, follow-up time will be censored at date of last contact.
次要结局
- Number of Participants Showing Stable Disease(12 months)
- Number of Participants Showing Complete or Partial Response(6 months)
- Progression-free Survival(6 months)
- Number of Participants Experiencing Adverse Events(6 months)
- Median Overall Survival of Participants(12 months)
研究者
研究点 (2)
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