NCT01342770终止2 期
Pioglitazone as a Candidate Chemoprevention Agent for Lung Cancer: A Pilot Trial Using a Pre-surgical Model in Early Stage NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Percent Change in Ki-67 by Immunohistochemistry (IHC)
研究概览
简要总结
This pilot phase II trial studies how well pioglitazone works in treating patients with stage IA-IIIA non-small cell lung cancer. Pioglitazone hydrochloride may slow the growth of tumor cells and may be an effective treatment for non-small cell lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the mechanism(s) of action of pioglitazone as a candidate chemopreventive agent for lung cancer by investigating the effects on Ki-67 defined in non-small cell lung cancer (NSCLC) tumor tissue.
SECONDARY OBJECTIVES:
I. To determine the effects of pioglitazone on multiple markers listed below:
- Tumor tissue: caspase-3, cyclin D1, p21/Waf1, peroxisome proliferative activated receptor, gamma (PPARγ), mucin 1 (MUC1).
- Premalignant tissue: Ki-67, caspase-3, PPARγ.
- Histologically normal tissue: Ki-67, PPARγ. II. To evaluate the toxicity and safety of pioglitazone in this patient population.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected or biopsy-proven NSCLC
- •Willingness to provide biopsy tissue for correlative studies
- •Candidate for pulmonary resection; must be able to schedule >= 14 days and =< 42 days between registration and surgery to allow for treatment with pioglitazone
- •Ability to understand and the willingness to sign a written informed consent document
- •Ability and willingness to swallow oral tablets
- •Ability and willingness to undergo two bronchoscopies (before treatment and at the time of surgery)
- •For those participants who are undergoing mediastinoscopy as part of their standard-of-care, the pre-treatment bronchoscopy may be performed during the mediastinoscopy; if the participant remains eligible for definitive surgical resection after the mediastinoscopy, the participant may proceed to registration and pioglitazone treatment
- •Current or former smoker with a >= 10 pack-year smoking history
- •Women of child-bearing potential and men who agree to use adequate contraception for the duration of study participation; women must not be pregnant or lactating; women of child-bearing potential (women considered not of childbearing potential if they are at least two years postmenopausal and/or surgically sterile) must have used adequate contraception (abstinence; barrier methods such as intrauterine device [IUD], diaphragm with spermicidal gel, condom, or others; and hormonal methods such as birth control pills or others) since her last menses prior to study entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
排除标准
- •Receiving any other investigational agents
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to pioglitazone
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant or lactating woman
- •Currently treated diabetes
- •Participants with >= class II New York Heart Association (NYHA) congestive heart failure or history of congestive heart failure
- •Participants with >= grade 2 (moderate) edema
- •Participants currently receiving an inhibitor of cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8) (gemfibrozil, ketoconazole, quercetin, trimethoprim), or an inducer of CYP2C8 (cortisol, dexamethasone, phenobarbital, rifampin), or cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) substrate
- •Prior neoadjuvant therapy for NSCLC
- •History of bladder cancer or in situ bladder cancer
研究组 & 干预措施
Treatment (pioglitazone hydrochloride)
Experimental
Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (pioglitazone hydrochloride)
Experimental
Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
干预措施: Pioglitazone Hydrochloride (Drug)
Treatment (pioglitazone hydrochloride)
Experimental
Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Percent Change in Ki-67 by Immunohistochemistry (IHC)
时间窗: Baseline and at the time of surgery, after 42 days of treatment
Changes in the expression levels of Ki-67 will be plotted graphically, and percent change in expression levels will be formally assessed using the paired t-test or the Wilcoxon signed rank test, if the assumptions of the t-test (i.e. normality) are not met.
次要结局
- Change in Apoptosis Assessment (e.g., Caspase-3)(Baseline and at the time of surgery, after 42 days of treatment)
- Change in Levels of Serum CA-153(Baseline and at the time of surgery, after 42 days of treatment)
- Change in Levels of Serum CRP(Baseline and at the time of surgery, after 42 days of treatment)
- Gene Expression Analysis of RNA From Bronchial Brush Cells(Up to the time of surgery, after 42 days of treatment)
- Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events Version 4.0(Up to the time of surgery, after 42 days of treatment)
- Number of Participants With Clinical Response, Based on Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1(Up to the time of surgery, after 42 days of treatment)
- Number of Participants With Complete Pathologic Response(Up to the time of surgery, after 42 days of treatment)
- Percent Change in Cyclin D1(Baseline to the time of surgery, after 42 days of treatment)
- Percent Change in MUC1(Baseline to the time of surgery, after 42 days of treatment)
- Percent Change in p21(Baseline to the time of surgery, after 42 days of treatment)
- Percent Change in PPARy(Baseline to the time of surgery, after 42 days of treatment)
- Percent Change in SUVmax From the PET Scan(Baseline to the time of surgery, after 42 days of treatment)
- Pre-intervention SUV of PET Scan(Baseline)
- Post-intervention SUV of PET Scan(Time of surgery, after 42 days of treatment)
研究者
研究点 (1)
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