EUCTR2006-004528-35-FR进行中（未招募）1 期
A multicenter, randomized, open label phase II trial evaluating the efficacy and safety of mFOLFOX7 plus weekly alternating sequential oral administration of BIBF 1120 250 mg twice daily and BIBW 2992 50 mg once daily (BB) versus mFOLFOX7 alone as first-line therapy in patients with metastatic colorectal cancer. -
Boehringer Ingelheim France SAS0 个研究点目标入组 90 人开始时间: 2007年1月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age >18 years.
- •2. Histologically proven colorectal adenocarcinoma.
- •3. Metastatic disease not suitable for curative-intent resection.
- •4. Measurable (= 1 cm) and evaluable disease (according to RECIST criteria).
- •5. No prior palliative chemotherapy for metastatic CRC.
- •6. No prior bevacizumab, cetuximab, Tyrosine Kinase Inhibitos (TKIs).
- •7. Previous adjuvant therapy with fluoropyrimidines is allowed if disease free survival after the end of chemotherapy is > 6 months.
- •8. Previous adjuvant therapy with oxaliplatin or irinotecan is allowed if disease free survival after the end of chemotherapy is >12 months.
- •9. ECOG performance status 0 or 1.
- •10. Adequate hepatic function.
- •- Total bilirubin within normal range, ALT and AST < 1.5x upper limit of normal (ULN).
- •- In patients with documented liver metastasis, total bilirubin < 1.5 x ULN, ALT and AST < 2.5 x ULN.
- •- Alkaline phosphatase < 3 x ULN.
- •- LDH < 5 x ULN.
- •11. Adequate Renal function.
- •- Serum creatinin < 1.5 ULN.
- •12. Adequate bone marrow function.
- •- Neutrophil count > 1,500/µl.
- •- Platelet count > 100,000/µl.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known hypersensitivity to the trial drugs or their excipients.
- •2. Treatment with any investigational drug within 28 days of trial onset.
- •3. Prior treatment with palliative standard chemotherapy for colorectal cancer, prior treatment with either cetuximab, bevacizumab or a tyrosine kinase inhibitor cf. inclusion criteria number 7 and 8).
- •4. History of other malignancies in the last 5 years, in particular those which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell skin cancer are generally eligible.
- •5. Serious concomitant disease, especially those that would limit compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the investigator would make the patient inappropriate for entry into the trial.
- •6. Major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion, or planned surgical procedures during the trial period.
- •7. Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 6 months, congestive heart failure > NYHA II).
- •8. History of severe haemorrhagic or thrombotic event in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis). Known inherited predisposition to bleeds or to thrombosis.
- •9. Patient with brain metastases that are symptomatic and/or require therapy.
- •10. Patients who require full-dose anticoagulation (INR >2.5).
- •11. Active alcohol or drug abuse.
- •12. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. abstinence, condom with spermicidal coating, diaphragm with spermicidal coating, oral contraceptive, progesterone implant, sterilisation) during the trial.
- •13. Pregnancy or breast-feeding
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