Randomized Double-blind Phase III Trial of FOLF(HA)Iri vs FOLFIRI for Second or Third Line Therapy in Irinotecan-naïve Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 390
- 试验地点
- 5
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Trial design:
-
Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with "Hyaluronic acid-Irinotecan" or "HA-Irinotecan") regimen.
-
Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve.
-
Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria, Poland, Serbia, Russia, Ukraine and the United Kingdom).
-
Dosing regimen:
-
Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan and HA-Irinotecan dose in must be reduced to 150 mg/m2).
-
Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan.
-
5-fluorouracil (5-FU), 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion.
-
Repeat every 2 weeks for 8 months.
-
Patient accrual over approximately 12-14 months.
-
Monitoring to 18 months post-randomization.
-
390 patients.
-
Progression Free Survival (PFS) primary endpoint.
-
Safety analysis on the initial 20 patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic colorectal cancer with disease progression after first or second line chemotherapy
- •Irinotecan naïve.
- •ECOG performance status of 0 or
- •Measurable disease, i.e. at least one measurable metastatic lesion (spiral CT or MRI).
- •Histological proof of colorectal cancer.
- •18 years of age and older.
- •Adequately recovered from and at least 4 weeks after recent surgery or chemotherapy.
- •Women of child-bearing potential (WOCBP) and male partners of WOCBP must agree to use adequate contraception.
- •Patient consent obtained and signed according to local and/or national ethics.
- •CT or MRI scan of chest/abdomen/pelvis within 21 days prior to randomization.
- •Hematology done within 14 days prior to randomization.
- •Chemistry done within 14 days prior to randomization.
排除标准
- •History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 5 years.
- •Locally advanced or recurrent disease only.
- •Unsuitability for irinotecan including known Gilbert's syndrome, active inflammatory bowel disease or chronic diarrhea greater than or equal to grade
- •Abdominal or pelvic radiation therapy within the last 12 months.
- •Women who are pregnant or breastfeeding.
- •Any condition (e.g., psychological, geographical) that would render the protocol treatment dangerous.
- •Significant cardiac disease.
- •Untreated or symptomatic brain or central nervous system (CNS).
- •Presence of pleural effusion or ascites requiring therapeutic thoracocentesis or paracentesis.
- •Current partial or complete bowel obstruction.
- •Concomitant active infection.
- •Enrolled in any other investigational trial, unless treatment in that trial has been discontinued at least 30 days prior to signing the Informed Consent for the ACO-002 study.
研究组 & 干预措施
FOLFIRI
干预措施: Irintoecan (Drug)
FOLF(HA)iri
干预措施: HA-Irinotecan solution for Infusion (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Approximately 20 months
次要结局
- Safety(After initial 20 patients receive 2 cycles, then 6 monthly thereafter.)