EUCTR2010-022162-27-DE进行中（未招募）1 期
FOLFOX/bevacizumab with or without irinotecan in first-line treatment for metastatic colorectal cancer. A randomized phase II study. - CHARTA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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) Patients with histologically confirmed diagnosis of unresectable stage IV (UICC) colorectal cancer (primary tumor may be present)
- •2) Patients with at least one measurable lesion, with size > 1 cm (RECIST v1.1)
- •3) ECOG Performance status = 2
- •4) Life expectancy > 3 months
- •5) Age = 18 years.
- •6) Haematologic function as follows: ANC = 1.5 x 109/L, platelets = 100 x109/L, hemoglobin = 9 g/dl or 5.59 mmol/l
- •7) INR <1.5 within 7 days prior to starting study treatment. aPTT < 1.5 x ULN within 7 days prior to starting study treatment.
- •8) Adequate liver function as measured by serum transaminases (AST & ALT) =< 2.5 x ULN (in case of liver metastases < 5 x ULN) and total bilirubin £ 1.5 x ULN
- •9) Adequate renal function: Serum creatinine =< 1.5 x ULN
- •10) Signed, written informed consent
- •11) At least 6 months after completion of adjuvant chemotherapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1) Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study.
- •2) Prior systemic or local treatment of metastatic disease.
- •3) Prior adjuvant or neo-adjuvant chemotherapy/radiotherapy completed less than 6 months prior to study entry.
- •4) Pre History or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures.
- •5) Fertile women (< 1 year after last menstruation) and men of childbearing potential unwilling or unable to use effective means of contraception.
- •6) Pregnancy or lactation.
- •7) Positive serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women < 1 year after the onset of menopause.
- •8) Other malignancies within the last 2 years prior to treatment start 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).
- •9) Peripheral neuropathy NCI CTCAE-grade = 1
- •10) Known DPD-insufficiency.
- •11) Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > 4 loose stools per day)
- •12) History of interstitial lung disease, haemoptoe or evidence of interstitial lung disease on baseline chest X-ray or CT scan.
- •13) Serious, non-healing wound, ulcer or bone fracture.
- •14) Thrombosis or severe bleeding within 6 months prior to entry into the study (except for bleeding of the tumor before its surgical resection) and no evidence of bleeding diathesis or coagulopathy.
- •15) Urine dipstick for proteinuria = 2+. If urine dipstick is = 2+, 24-hour urine must demonstrate =< 1 g of protein in 24 hours for patient to be eligible.
- •16) Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment.
- •17) Clinically significant cardiovascular disease, for example CVA, myocardial infarction, unstable angina, NYHA Class II CHF, arrhythmia requiring medication, or uncontrolled hypertension.
- •18) 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.
- •19) Known hypersensitivity or contraindication to the drugs used in the trial (eg: 5-FU, folinic acid/ leucovorin, capecitabine, oxaliplatin, bevacizumab, irinotecan)
- •20) Concomitant treatment with ASS > 325 mg or NSAIDs, known to inhibit platelet function, sorivudin or analog compounds or preparations of St. John’s wort
- •21) Inability or unwillingness to comply with the protocol
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