NCT03168594终止2 期
A Randomized, Controlled Phase II Study to Compare Irinotecan Combined With Cisplatin (IP) Versus Etoposide Combined With Cisplatin (EP) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Carcinoma
Peking University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年4月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
The study will be conducted to compare the safety and efficacy of irinotecan combined with cisplatin (IP regimen) and etoposide combined with cisplatin (EP regimen) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine carcinoma.
In this prospective randomized phase II study, the investigators aim to compare the survival benefit as well as the safety for irinotecan combined with cisplatin (IP regimen) versus etoposide combined with cisplatin (EP regimen) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine carcinoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sign written informed consent form
- •age ≥ 18 years
- •pathologically confirmed poorly-differentiated neuroendocrine carcinoma, G3(Ki67>20%);
- •No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy. For recurrent patients after radical surgery, adjuvant chemotherapy should not include irinotecan, cisplatin or etoposide, and the last date should beyond 6 months prior to randomization;
- •At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions);
- •Screening laboratory values must meet the following criteria (within past 7 days): hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10^3/ μL; total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1╳ULN;
- •Predicted survival >=3 months;
- •Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women;
- •Sexually active males or females willing to practice contraception during the study until 30 days after end of study.
排除标准
- •Hypersensitivity to IRI, DDP, VP-16,5-HT3 receptor antagonists;
- •Prior antitumor therapy (including corticosteroids and immunotherapy) or participation in other clinical trials within past 4 weeks, or have not recovered from toxicities since the last treatment;
- •Received surgery within past 4 weeks, or have not recovered from surgery;
- •Severe diarrhea;
- •Concurrent severe infection；
- •Severe, uncontrolled medical condition that would affect patients' compliance or obscure the interpretation of toxicity determination or adverse events, including severe liver disease (active hepatitis, cirrhosis), uncontrolled diabetes or hypertension, or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm);
- •Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment)；
- •Meningeal carcinomatosis;
- •Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease；
- •Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency；
- •Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;
- •History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible；
- •Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons；
- •Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.
研究组 & 干预措施
A:Irinotecan combined with cisplatin (IP regimen)
Experimental
patients in arm A will receive chemotherapy of IP regimen: Irinotecan：60mg/m2 ，iv drip for 90min，d1,8 q3W cisplatin: 60mg/m2 ，iv drip for 120min，d1 q3W
干预措施: irinotecan cisplatin (Drug)
B:Etoposide combined with cisplatin (EP regimen)
Experimental
patients in arm B will receive chemotherapy of EP regimen: Etoposide：100mg/m2 ，iv drip for 60min，d1-3 q3W cisplatin: 75mg/m2 ，iv drip for 120min，d1 q3W
干预措施: Etoposide cisplatin (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1
次要结局
- Incidence of Treatment-Emergent Adverse Events （Safety and Tolerability）(From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Progression-free survival(baseline, every 8 weeks up to 1 year after last patient first treatment)
- Overall survival(baseline, every 8 weeks up to 1 year after last patient first treatment)
研究者
Shen Lin
MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital
Peking University
研究点 (1)
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