NCT00433927Unknown3 期
Multicenter Randomized Trial Evaluating FOLFIRI Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment of Metastatic Colorectal Cancer.
PD Dr. med. Volker Heinemann1 个研究点 分布在 1 个国家目标入组 568 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 568
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
The FIRE-3 trial is a multicenter randomized phase III trial investigating 5-FU, folinic acid and irinotecan (FOLFIRI) plus cetuximab versus FOLFIRI plus bevacizumab in first line treatment of metastatic colorectal cancer. Planned accrual is 284 evaluable patients per treatment arm. The primary study endpoint is objective response rate. Secondary endpoints are median progression free survival, median overall survival, safety, and secondary resection rate.
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
- •KRAS-Wildtype status
- •Histologically confirmed adenocarcinoma of the colon or rectum.
- •Stage IV disease.
- •Patients considered suitable for application of chemotherapy.
- •Age 18 - 75 years.
- •In- or outpatient treatment.
- •Estimated life expectancy > 3 months.
- •Measurable index lesion according to RECIST criteria. Evaluation of tumor manifestations ≤ 2 weeks prior to treatment start.
- •Effective contraception.
- •Adequate hematologic function: leukocytes >= 3000/µl, neutrophils >= 1500/µl, platelets >= 100.000/µ, and hemoglobin >= 9g/dl.
- •Bilirubin <= 1,5x upper limit of normal (ULN).
- •ALAT and ASAT <= 2,5x ULN, in case of liver metastases <= 5x ULN.
- •Serum creatinine <= 1,5x ULN.
- •No operations within 4 weeks prior to treatment start. No cytologic biopsies within 1 week prior to treatment start. Operation sequels need to be completely healed. Major operations must not be expected at time of study begin, except for potential secondary resection of liver metastases. In case of secondary resection of liver metastases, bevacizumab must be discontinued 6-8 weeks prior to surgery.
- •No relevant toxicities due to prior medical treatment at time of study entry.
排除标准
- •KRAS-Mutation of the tumor
- •Prior treatment directed against the epidermal growth factor receptor (EGFR).
- •Prior treatment with bevacizumab.
- •Prior chemotherapy for colorectal cancer, except for adjuvant chemotherapy dating back > 6 months prior to study entry.
- •Experimental medical treatment within 30 days prior to study entry.
- •Known hypersensitivity reaction to any study medication.
- •Pregnant or breast feeding women (pregnancy needs to be excluded by testing of beta-HCG).
- •Known or suspected cerebral metastases.
- •Clinically significant coronary heart disease, myocardial infarction within the last 12 months or high risk of uncontrolled arrhythmia.
- •Acute or subacute ileus, chronic inflammatory bowel disease or chronic diarrhea.
- •Symptomatic peritoneal carcinosis.
- •Severe chronic wounds, ulcera or bone fracture.
- •Uncontrolled hypertension.
- •Severe proteinuria (nephrotic syndrome).
- •Arterial thromboembolic events or hemorrhage within 6 months prior to study entry (except tumor bleeding surgically treated by tumor resection).
- •Bleeding diatheses or coagulopathy.
- •Full dose anticoagulation.
- •Known DPD-deficiency (special screening not required).
- •Known glucuronidation-deficiency (special screening not required).
- •Medical history of other malignant disease within 5 years prior to study entry, except for basalioma, and in-situ cervical carcinoma if treated with curative intent.
- •Known alcohol or drug abuse.
- •Medical or psychiatric condition which contradicts participation of study.
- •Limited legal capacity.
研究组 & 干预措施
Arm A
Active Comparator
FOLFIRI plus Cetuximab
干预措施: 5-FU (Drug)
Arm A
Active Comparator
FOLFIRI plus Cetuximab
干预措施: folinic acid (Drug)
Arm A
Active Comparator
FOLFIRI plus Cetuximab
干预措施: irinotecan (Drug)
Arm A
Active Comparator
FOLFIRI plus Cetuximab
干预措施: cetuximab (Drug)
Arm B
Active Comparator
FOLFIRI plus Bevacizumab
干预措施: 5-FU (Drug)
Arm B
Active Comparator
FOLFIRI plus Bevacizumab
干预措施: folinic acid (Drug)
Arm B
Active Comparator
FOLFIRI plus Bevacizumab
干预措施: irinotecan (Drug)
Arm B
Active Comparator
FOLFIRI plus Bevacizumab
干预措施: bevacizumab (Drug)
结局指标
主要结局
Objective response rate
时间窗: approximate 6 months after randomisation
次要结局
- Median progression free survival(approximate 6 months after randomisation)
- Median overall survival(approximate 3 years after randomisation)
- Secondary resection rate with curative intent(up to 3 months after end of treatment)
- Safety and toxicity (according to NCI-CTCAE)(approximate 6 months after randomisation)
研究者
PD Dr. med. Volker Heinemann
Sponsor Delegated Person
Ludwig-Maximilians - University of Munich
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal CancerMetastatic Colorectal CancerNCT00457691Pfizer768
已完成
2 期
Randomized Phase II Study of FOLFOX Versus FOLFIRI.3 in Gemcitabine-refractory Pancreatic CancerMetastatic Pancreatic CancerNCT00786006Asan Medical Center61
已完成
3 期
An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With RuxolitinibPost-Polycythemia VeraMyelofibrosisPrimary MyelofibrosisNCT03952039Celgene202
已完成
3 期
An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)Coronary Artery Disease (CAD)NCT03354273GE Healthcare730
招募中
3 期
High Dose IV Iron Plus ESA in Chemotherapy-induced AnemiaAnemiaNCT05768997Hallym University Medical Center312