NCT00889343终止2 期
A Controlled Randomized Double-blind Multi-center Phase II Study of FOLFOX6 or FOLFIRI Combined With Sorafenib Versus Placebo in Second-line Metastatic Colorectal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 101
- 试验地点
- 56
- 主要终点
- To compare the PFS between patients receiving chemotherapy (FOLFOX6 or FOLFIRI) + sorafenib with chemotherapy + placebo
研究概览
简要总结
The purpose of this study is to determine whether sorafenib in combination with chemotherapy has a positive effect on time to progression of the tumor or death for the treatment of large bowel cancer that has already progressed during a first chemotherapy.
详细描述
Patients with metastatic CRC who received a first-line therapy with an Oxaliplatin- or Irinotecan based Fluoropyrimidine containing regimen ± bevacizumab and had a progression subsequently, are eligible for this study. Patients will be randomized to receive chemotherapy (FOLFOX6 or FOLFIRI) + sorafenib 400 mg bid or chemotherapy + placebo. Patients who have received an Oxaliplatin based Fluoropyrimidine containing regimen in first-line will obtain FOLFIRI during this study. Patients who have received an Irinotecan based Fluoropyrimidine containing regimen in first-line will obtain FOLFOX6.
Primary objective of the study is to compare the Progression-free-survival (PFS) between patients receiving chemotherapy (FOLFOX6 or FOLFIRI) + sorafenib with chemotherapy + placebo.
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
- •Age > 18 years.
- •ECOG Performance Status of 0 to 2
- •Life expectancy of at least 12 weeks.
- •Subjects with at least one uni-dimensional (RECIST) measurable lesion of metastatic colorectal carcinoma after first-line chemotherapy with an Oxaliplatin- or Irinotecan based Fluoropyrimidine containing regimen ± bevacizumab and had a progression subsequently. Lesions must be measured by CT-scan or MRI.
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •Hemoglobin > 9.0 g/dl
- •Absolute neutrophil count (ANC) >1,500/mm3
- •Platelet count 100,000/μl Total bilirubin < 1.5 times the upper limit of normal
- •ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
- •Alkaline phosphatase < 4 x upper limit of normal
- •PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
- •Serum creatinine < 1.5 x upper limit of normal
- •Signed and dated informed consent before the start of specific protocol procedures
排除标准
- •History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
- •History of HIV infection or chronic hepatitis B or C
- •Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- •Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
- •Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- •History of organ allograft
- •Patients with evidence or history of bleeding diathesis
- •Patients undergoing renal dialysis
- •Known deficit in Dihydropyrimidine Deshydrogenase (DPD)
- •Contraindications for the use of atropine in patients receiving FOLFIRI
- •Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
- •Peripheral sensory neuropathy > CTC grade 2
- •Chronic inflammatory bowel disease; ileus; genetic fructose intolerance
- •Pregnant or breast-feeding patients.
- •Women of childbearing potential must have a negative pregnancy test performed within 7 days before the start of treatment. Fertile women and men (<2 years after last menstruation in women) must use effective means of contraception (intrauterine contraceptive device, contraceptive implants, injectables (hormonal depot), transdermal hormonal contraception (contraceptive patch), sexual abstinence or vasectomised partner) during treatment and for at least 6 months after last administration of medication.
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient"s participation in the study or evaluation of the study results
- •Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- •Patients unable to swallow oral medications.
- •Any other anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
- •Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 4 weeks of start of study
- •Autologous bone marrow transplant or stem cell rescue within 4 months prior to study treatment
- •Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however, they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
- •Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- •Prior exposure to the study drug.
- •Any St. John´s wort containing remedy
研究组 & 干预措施
2
Placebo Comparator
干预措施: Leucovorin (Drug)
1
Experimental
干预措施: Sorafenib (Drug)
1
Experimental
干预措施: Oxaliplatin or Irinotecan (Drug)
1
Experimental
干预措施: Leucovorin (Drug)
1
Experimental
干预措施: 5-Fluorouracil (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
2
Placebo Comparator
干预措施: Oxaliplatin or Irinotecan (Drug)
2
Placebo Comparator
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
To compare the PFS between patients receiving chemotherapy (FOLFOX6 or FOLFIRI) + sorafenib with chemotherapy + placebo
时间窗: 6 to 12 months
次要结局
- Safety(signature of informed consent until 30 days after end of treatment)
- Overall survival(6 to 12 months)
- Response rates(6 to 12 months)
- Disease control rate(6 to 12 months)
研究者
研究点 (56)
Loading locations...
相似试验
已完成
2 期
A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).Carcinoma, HepatocellularNCT00855218Bayer307
已完成
2 期
Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) SubjectsMetastatic Colorectal CancerNCT00865709Bayer198
已完成
2 期
Efficacy of Sorafenib Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AMLAcute Myeloid LeukemiaNCT00373373University Hospital Muenster200
已完成
2 期
Sorafenib Therapy Prior to Radiofrequency Ablation for Intermediate Sized Hepatocellular CancerHepatocellular CancerNCT00813293Beth Israel Deaconess Medical Center20
已完成
1 期
Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate CancerProstate CancerNCT00414388Oncology Specialists, S.C.22