An Open, Randomized, Parallel Control, Multiple-center Phase II Trial of Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- progression-free survival
研究概览
简要总结
As the gene polymorphism of uridine diphosphate glucuronosyl transferase 1A1(UGT1A1)is related to the side effect of diarrhea induced by irinotecan. UGT1A1 gene *28 (6/6 and 6/7) and *6 (G/G and G/A) is related to low probability of diarrhea and UGT1A1 gene *28 (7/7) and *6 (A/A)is related to high probability of diarrhea. The purpose of this study is to find out the efficacy and side effect between two different dosages of irinotecan combined with cisplatin scheme in extensive disease-small cell lung cancer with UGT1A1 gene *28 (6/6 and 6/7)and *6 (G/G and G/A), based on the hypothesis that the UGT1A1 gene *28 (7/7) and *6 (A/A)is few in the Chinese population and increasing the dose of irinotecan can improve the efficacy without increasing the side effect in the patients with UGT1A1 gene *28 (6/6 and 6/7)*6 (G/G and G/A).
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
- None
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 small-cell lung cancer
- •Extensive-stage disease, defined as disease extending beyond one hemithorax involving contralateral mediastinal, hilar or supraclavicular lymph nodes, and/or pleural effusion.
- •Males or females between 18 to 75 years
- •No prior chemotherapy, if the surgery or radiotherapy has been administered, the interval is at least above four weeks.
- •Performance status of 0-2 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).
- •Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative.
- •Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNL x 1.5), and renal (creatinine =< UNL) function
- •The gene type of UGT1A1 *28 is 6/6 and 6/
- •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 3 months after trial. If male, use of an approved contraceptive method during the study and 3 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
- •Non small cell lung cancer and carcinoid
- •Medically uncontrolled severe diarrhea in recent three weeks.
- •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
研究组 & 干预措施
Arm A
Irinotecan 90mg/m2/iv over 90min and cisplatin 30mg/m2/iv over 60min on day 1 and 8, repeat Q 3weeks. Four cycles.
干预措施: Irinotecan (Drug)
Arm A
Irinotecan 90mg/m2/iv over 90min and cisplatin 30mg/m2/iv over 60min on day 1 and 8, repeat Q 3weeks. Four cycles.
干预措施: Cisplatin (Drug)
Arm B
Irinotecan 65mg/m2/iv over 90min and cisplatin 30mg/m2/iv over 60min on day 1 and 8, repeat Q 3weeks. Four cycles.
干预措施: Irinotecan (Drug)
Arm B
Irinotecan 65mg/m2/iv over 90min and cisplatin 30mg/m2/iv over 60min on day 1 and 8, repeat Q 3weeks. Four cycles.
干预措施: Cisplatin (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; assessed up to 3 years
次要结局
- overall survival(the first day of treatment to death or last survival confirm date; assesed up to 3 years)
- Tumor response rate(Up to 3 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
Xueqin Yang
associate chief physician
Third Military Medical University