NCT00593008终止1 期
A Phase 1 Study of Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus
研究概览
简要总结
The purpose of this research study is to try to define the highest doses of temsirolimus and gemcitabine that can be used safely in combination to treat advanced pancreatic cancer. Gemcitabine is a standard chemotherapy used for the treatment of pancreatic cancer.
详细描述
- Because this is a study to determine the highest doses of temsirolimus and gemcitabine that can be given safely together, groups of 3 subjects will be treated at gradually increasing doses of the drugs. Each group of 3 subjects must complete 4 weeks of treatment (1 cycle) before the following group of 3 subjects can start treatment at the higher dose of drug.
- Temsirolimus will be given intravenously every week of the 28 day treatment cycle (days 1, 8, 15, 22). Gemcitabine will be given intravenously every other week of the treatment cycle (days 1. 15).
- During the study, participants will have weekly clinic visits where the following tests and procedures may be performed: Physical exam; vital signs; urine test; blood tests.
- A CT scan will be performed after every 2 cycles (8 weeks) to assess teh response of the tumor to the study treatment.
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
- •Previously untreated metastatic pancreatic adenocarcinoma, histologically proven.
- •Measurable disease by RECIST criteria
- •ECOG Performance Status 0 or 1
- •Male or female, 18 years of age or older
- •Life expectancy of >/= 12 weeks
- •AST and ALT </= 2.5 x ULN
- •Total bilirubin </= 1.5 x ULN
- •Serum albumin >/= 2.5g/dL
- •Absolute neutrophil count >/= 1500/mm3; platelets >/= 100,000/mm3; hemoglobin >/= 9.0 g/dL
- •Serum creatinine </= 1.5 x ULN
- •Subjects with diabetes must have adequate glycemic control, with fasting serum glucose </= 1.5 x ULN
- •Female patients of childbearing age and male patients with partners of childbearing age must agree to use adequate birth control measures during the course of the study and for at least one month following withdrawal from the study
排除标准
- •Previously treatment with gemcitabine or chemoradiation
- •Diagnosis of a second malignancy within the last 3 years, except for adequately treated basal cell carcinoma or squamous cell skin cancer
- •Ongoing cardiac dysrhythmias of NCI CTCAE grade >/= 2, atrial fibrillation, QTc prolongation to > 450 msec for males and >470 msec for females
- •Known immunodeficiency disorders or active infections requiring treatment
- •Pregnancy or breastfeeding
- •Known brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
- •Prior radiation therapy or major surgery within 4 weeks of study entry
- •Prior radiation therapy to > 25% of the bone marrow
- •Subjects receiving other experimental or alternative therapies during the course of the trial will be excluded
- •History of prior hypersensitivity to polysorbate
结局指标
主要结局
To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus
时间窗: 2 years
To determine whether order of administration of the drugs affects the above
时间窗: 2 years
To determine the dosing regimen appropriate for Phase 2 studies of the combination
时间窗: 2 years
次要结局
- To document objective response rate and progression-free survival in patients treated with this combination
研究者
Eunice L. Kwak, MD, PhD
Assistant in Medicine
Massachusetts General Hospital
研究点 (2)
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