EUCTR2004-004021-98-ES进行中（未招募）1 期
A single arm Phase IV study to assess efficacy and safety of bevacizumab in combination with irinotecan and infusional 5-fluorouracil/folinic acid regimens as first line treatment for patients with metastatic colorectal cancer. - N/A
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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. Written informed consent (approved by the Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures.
- •2. Age =18 years
- •3. Patient must be able to comply with the protocol.
- •4. Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases (new confirmation of metastatic disease is required in case the time interval from last histological/cytological diagnosis to enrolment exceeds 3 years).
- •5. Diagnosis of metastatic disease for which treatment will have to be started not more than 3 months prior to enrolment.
- •6. Life Expectancy of at least 3 months.
- •7. At least one measurable metastatic lesion (as per RECIST criteria)
- •8. Prior adjuvant or neo-adjuvant chemotherapy/radiotherapy allowed if completed more than 6 months before inclusion.
- •9. ECOG performance score of 0 or 1
- •10. Adequate haematological function: ANC =1.5 x 10(9)/L; platelets = 100 x 10(9)/L, Hb =9 g/dL
- •11. INR = 1.5; aPTT = 1.5 x ULN within 7 days prior to starting study treatment
- •12. Adequate liver function: Serum bilirubin = 1.5 x ULN; alkaline phosphatase and transaminases = 2.5 x ULN (in case of liver metastases < 5 x ULN)
- •13. Serum Creatinine = 1.5 x ULN
- •14. Urine dipstick for proteinuria < 2+. If urine dipstick is = 2+, 24- hour urine must demonstrate = 1 g of protein in 24 hours.
- •15. Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women < 2 years after the onset of menopause. This test has to be reconfirmed by a urine test, should the 7 days window be exceeded.
- •Fertile women and men of childbearing potential (<2 years after last menstruation in women) must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).
- •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. Patients who received adjuvant irinotecan or antiVEGF treatment
- •2. Prior chemotherapeutic treatment for metastatic CRC
- •3. Clinical evidence of brain metastases
- •4. Past or current history (within the last 2 years prior to treatment start) of other malignancies except metastatic colorectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
- •5. Clinically significant cardiovascular disease, for example CVA (= 6 months before treatment start), myocardial infarction (= 6 months before treatment start), unstable angina, NYHA = grade 2 CHF, arrhythmia requiring medication, or uncontrolled hypertension.
- •6. Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study.
- •7. Known hypersensitivity to any of the study drugs.
- •8. Current or recent (within 10 days of first dose of study treatment) chronical use of aspirin (> 325 mg/day) or other NSAID with anti-platelet activity.
- •9. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes.
- •10. History of thromboembolic or haemorrhagic events within 6 months prior to treatment.
- •11. Evidence of bleeding diathesis or coagulopathy.
- •12. Serious, non healing wound, ulcer, or bone fracture.
- •13. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study. CVAD for chemotherapy administration inserted within 2 days prior to study treatment start.
- •14. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
- •15. Pregnancy or lactation
- •16. Fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
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