Trial of FOLF(HA)Iri With Cetuximab in mCRC
关键词
抽象
日期
| 最后验证: | 07/31/2014 |
| 首次提交: | 08/11/2014 |
| 提交的预估入学人数: | 08/11/2014 |
| 首次发布: | 08/14/2014 |
| 上次提交的更新: | 08/26/2014 |
| 最近更新发布: | 08/28/2014 |
| 实际学习开始日期: | 05/31/2014 |
| 预计主要完成日期: | 05/31/2016 |
| 预计完成日期: | 10/31/2016 |
状况或疾病
干预/治疗
Drug: HA-Irinotecan
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: HA-Irinotecan HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan. | Drug: HA-Irinotecan HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan for treatment of mCRC. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion criteria - Tumour is KRAS wild type - mCRC with disease progression after first-line chemotherapy (adjuvant chemotherapy is considered first line chemotherapy if metastatic progression occurs within 6 months of the end of the adjuvant chemotherapy). - Irinotecan naïve - Prior use of bevacizumab in the 1st line setting is permitted. - ECOG 0 or 1 - Measurable disease - Histological proof of colorectal adenocarcinoma - 18+ years of age - Adequately recovered from and at least 4 weeks after recent major surgery or chemotherapy - At least 4 weeks after treatment with a biologic monotherapy from last dose to enrolment. - Hematology done within 14 days prior to enrolment : - Absolute Neutrophil count (ANC) greater than 1.5 x 109/L - Platelets greater than 100 x 109/L - Hemoglobin greater than or equal to 100g/L - Chemistry done within 14 days prior to enrolment: - AST greater than or equal to 2.5 X ULN (greater than 5 X ULN if elevation thought to be related to hepatic metastatic disease), - Alkaline phosphatase greater than 5 x ULN, - Serum creatinine greater than 1.5 x ULN, - Total bilirubin greater than 34.2 µmol/L, - Negative serum or urine pregnancy test if a WOCBP. Exclusion criteria - KRAS mutant. - Prior irinotecan - Prior anti-EGFR - History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than 5 years. - Locally advanced or recurrent disease only - Unsuitability for irinotecan - Abdominal or pelvic radiation therapy (including treatment with SIR-Spheres/Sirtex) within the last 12 months. - Women who are pregnant or breastfeeding. - Significant cardiac disease - Untreated or symptomatic brain or central nervous system (CNS) metastases - Presence of pleural effusion or ascites requiring therapeutic thoracocentesis or paracentesis. - Current partial or complete bowel obstruction. - Concomitant active infection. |
结果
主要结果指标
1. Safety [2 years]
