Neoadjuvant Therapy of Gastric Cancer With Irinotecan, Cisplatin and Cetuximab Followed by Surgical Resection and Adjuvant Chemoradiation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab
研究概览
简要总结
This study intends to evaluate the feasibility and treatment efficacy of adding an antibody blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven efficacy developed at New York University.
详细描述
The overall objective of this study is the development of definitive treatments for patients with locally advanced gastric cancer. To this end, this trial is evaluating the feasibility and treatment efficacy of adding an antibody blocking the EGF pathway to a neoadjuvant approach with proven efficacy developed at New York University (NYU). The combination of Irinotecan and Cisplatin has been shown to be synergistic and active against gastric carcinoma. This trial therefore builds upon NYU previous experience with the neoadjuvant administration of Irinotecan combined with Cisplatin as well as the reported enhanced activity of Irinotecan, Cisplatin and External beam radiation when combined with Cetuximab to develop a novel neoadjuvant and adjuvant approach for the treatment of gastric and gastro-esophageal junction (GEJ) cancers. The program includes: 1) systemic combination of Irinotecan, Cisplatin and Cetuximab used as an induction, 2) followed by potentially curative gastrectomy or GEJ resection, and 3) post-operative chemoradiation as reported in the Intergroup study with the addition of Cetuximab.
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
- •Patients must have signed an approved informed consent.
- •must have histologically documented untreated gastric/GEJ carcinoma (clinical stage T3 N0 or T4, or any T with N1-N3 M0)
- •Patients with tumor tissue available for assessment of EGF receptor status by immuno-histochemistry (IHC).
- •Patients with Performance Status 0-
- •Patients, 18 years and older, must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- •Bone marrow function: absolute neutrophil count (ANC) at least 1,500/ul; platelets at least 100,000/ul.
- •Renal function: creatinine not greater than 1.5 x institutional upper limit of normal (ULN).
- •The PT and PTT should be within the range of normal values
- •Hepatic function: bilirubin not greater than 1.5 x ULN; aspartate aminotransferase (AST) not greater than 2.5 x ULN.
排除标准
- •Acute hepatitis or known HIV.
- •Active or uncontrolled infection.
- •Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, and congestive heart failure.
- •Prior therapy that affects or targets the EGF pathway.
- •Prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA).
- •Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
研究组 & 干预措施
Induction/ surgery/ chemoRT
- Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
- Surgery (starts 3-4 weeks after induction treatment).
- Chemoradiation treatment (starts 4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
干预措施: Cetuximab (Drug)
Induction/ surgery/ chemoRT
- Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
- Surgery (starts 3-4 weeks after induction treatment).
- Chemoradiation treatment (starts 4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
干预措施: Irinotecan (Drug)
Induction/ surgery/ chemoRT
- Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
- Surgery (starts 3-4 weeks after induction treatment).
- Chemoradiation treatment (starts 4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
干预措施: Cisplatin (Drug)
Induction/ surgery/ chemoRT
- Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
- Surgery (starts 3-4 weeks after induction treatment).
- Chemoradiation treatment (starts 4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
干预措施: Surgery (Procedure)
Induction/ surgery/ chemoRT
- Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
- Surgery (starts 3-4 weeks after induction treatment).
- Chemoradiation treatment (starts 4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
干预措施: 5-FU (Drug)
Induction/ surgery/ chemoRT
- Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
- Surgery (starts 3-4 weeks after induction treatment).
- Chemoradiation treatment (starts 4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
干预措施: Radiation (Radiation)
结局指标
主要结局
Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab
时间窗: 4 months from the beginning of the induction regimen
Clinical response rate is defined as the percentage of patients who responded to the induction regimen. The response is determined based on endoscopic ultrasonography (EUS) staging pre-treatment and post-treatment, CT scans pre- and post- operatively, and initial clinical stage (based on these tests) compared with the pathologic stage. Any "down-staging" of T or N stage is considered to be a result of induction therapy and counted as a clinical response.
次要结局
- Median Overall Survival (Induction Treatment and Curative Surgery)(up to 5 years)
- Median Overall Survival (Adjuvant Therpary)(up to 5 years)
- Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy(4 months from the beginning of the induction treatment)
- Rate of Potentially Curative Surgery(4 months from the beginning of the induction treatment)
- Rate of "Down-staging" From Pre-operative Clinical Staging(4 months from the beginning of the induction treatment)
- Safety of the Induction Regimen(4 months from the beginning of the induction)