NCT01977209Unknown3 期
A Randomized, Double Blind, Placebo-controlled Multiple-center Phase III Trial of Gossypol Combined With Docetaxel and Cisplatin Scheme in Advanced Non Small-cell Lung Cancers With APE1 High Expression
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 204
- 试验地点
- 6
- 主要终点
- Progression-free survival
研究概览
简要总结
The investigators' experimental study found that gossypol was the natural inhibitor of apyrimidinic endonuclease 1 (APE1) and clinical study observed that high expression of APE1 was relative to the platinum-resistance in non-small cell lung cancer. Thus the purpose of this study is to find out whether gossypol can improve the sensitivity of cisplatin-based chemotherapy in the non-small cell lung cancer with apurinic apyrimidinic endonuclease 1 (APE1) high expression
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of NSCLC, Stage IIIB/IV.
- •Males or females between 18 Years to 75 Years.
- •No prior cisplatin-based chemotherapy, if the surgery or radiotherapy has been administered, the interval is at least above four weeks. The interval for targeted therapy such as EGFR TKI is above 2 weeks.
- •Performance status of 0, 1 on the ECOG criteria. Expected survival is above three months.
- •At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
- •Patients can have the brain / meningeal metastasis history, but the metastasis must be treated by operation or radiotherapy), and clinically stable for at least 2 months.
- •Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function.
- •Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative.
- •APE1 IHC (++ or +++).
- •If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 2 months after trial. If male, use of an approved contraceptive method during the study and 2 months afterwards. Females with childbearing potential must have a urine negative HCG test within 7 days prior to the study enrollment.
- •No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital, phenytoin, ketoconazole.
排除标准
- •Inability to comply with protocol or study procedures.
- •Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease.
- •Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- •Pregnant or breast-feeding.
- •Enrollment in other study within 30 days.
- •Brain metastasis with symptoms.
- •Hypokalemic periodic paralysis history.
研究组 & 干预措施
Arm A
Experimental
Docetaxel 75mg/m2/iv over 90min and cisplatin 75mg/m2/iv over 90min on day 1. Gossypol 20mg from day 1 to day 14. repeat Q 3weeks. Four cycles.
干预措施: Gossypol (Drug)
Arm B
Placebo Comparator
Docetaxel 75mg/m2/iv over 90min and cisplatin 75mg/m2/iv over 90min on day 1. Placebo from day 1 to day 14. repeat Q 3weeks. Four cycles.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-free survival
时间窗: the first day of treatment to the date that disease progression is reported; assesed up to 4 years
次要结局
- Overall survival(the first day of treatment to death or last survival confirm date; assesed up to 4 years)
- Tumor response rate(Up to 4 years)
- Toxicity(the first date of treatment to 30 days after the last dose of study drug)
- Quality of life(the day before every cycle of chemotherapy; 30 days after the last dose of study drug)
研究者
Dong Wang
chief physician
Third Military Medical University
研究点 (6)
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