NCT00659568已完成1 期
A Phase I Study of Temsirolimus in Combination With Metformin in Advanced Solid Tumours
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus
研究概览
简要总结
RATIONALE: Metformin and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of metformin when given together with temsirolimus in treating patients with metastatic or unresectable solid tumor or lymphoma.
详细描述
OBJECTIVES:
Primary
- To establish the maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus in patients with advanced solid cancers or lymphoma.
Secondary
- To determine the toxicity and safety, with particular reference to glucose and lipid deregulation, of this regimen in these patients.
- To assess antitumor activity, including tumor response rate and time to progression, in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignancy, including any of the following types:
- •Renal cell
- •Endometrial
- •Small cell lung carcinoma
- •Metastatic or unresectable disease for which standard curative or palliative measures do not exist or are no longer effective
- •Measurable disease according to RECIST criteria
- •No unstable primary CNS tumors or metastases
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- •Life expectancy > 12 weeks
- •Absolute neutrophil count ≥ 1.5 x 10^9/L
- •Platelets ≥ 100 x 10^9/L
- •AST ≤ 2.5 times upper limit of normal (ULN)
- •Serum creatinine ≤ ULN
- •Serum bilirubin ≤ 1.5 times ULN
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Able to understand and willing to sign a written informed consent document
排除标准
- •Allergies to or a history of allergic reactions attributed to any other compound of similar chemical or biologic composition to temsirolimus or metformin
- •Diabetes mellitus (type I or II)
- •Uncontrolled hypertriglyceridemia (triglyceride levels > 10 mmol/L)
- •History of lactic acidosis
- •Inability to swallow or digest oral medications
- •Uncontrolled intercurrent illness including, but not limited to, any of the following:
- •Uncontrolled hypertension
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness/social situation that would limit compliance with study requirements
- •Significant traumatic injury within 21 days prior to treatment
- •PRIOR CONCURRENT THERAPY:
- •Inclusion criteria:
- •Recovered from all prior therapy
- •At least 4 weeks since prior chemotherapy or radiotherapy (6 weeks for carmustine or mitomycin C) except low-dose, non-myelosuppressive radiotherapy
- •No limitation on other prior therapy
- •Concurrent low-dose anticoagulant (i.e., warfarin) allowed provided INR ≤ 1.1 times ULN
- •Concurrent full-dose anticoagulant (i.e., warfarin) allowed provided INR is within institutional therapeutic range (usually 2.0-3.0)
- •Exclusion criteria:
- •Major surgery within the past 21 days
- •Prior temsirolimus (or other known inhibitors of mammalian target of rapamycin) or metformin
- •Concurrent combination antiretroviral therapy for HIV-positive patients
- •Concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., phenytoin, carbamazepine, or phenobarbital) or other CYP3A4 inducer (e.g., rifampin or Hypericum perforatum [St. John's wort])
- •Concurrent investigational or commercial agents or therapies to treat the patient's malignancy
- •Other concurrent investigational agents other than temsirolimus or metformin
结局指标
主要结局
Maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus
次要结局
- Objective response
- Toxicity and safety, with particular reference to glucose and lipid deregulation
- Survival
- Antitumor activity, including tumor response rate and time to progression
- Frequency and severity of adverse events
研究者
研究点 (1)
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