EUCTR2012-005657-24-DE进行中（未招募）1 期
Personalized marker-driven early switch to aflibercept in patients with metastatic colorectal cancer. A run in marker determination phase followed by a marker-driven randomized part - a multicenter, multinational, two-part, phase II trial.
niversitätsklinikum Ulm0 个研究点目标入组 200 人开始时间: 2014年6月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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.Patients with histologically confirmed diagnosis of colorectal cancer presenting with unresectable stage IV (UICC) disease (primary tumor may be present)
- •2.Patients with at least one measurable lesion, with size > 1 cm (RECIST v1.1)
- •3.ECOG Performance status = 1
- •4.Life expectancy > 3 months
- •5.Age =18 years.
- •6.Haematologic function: ANC = 1.5 x 109/L, platelets = 100 x109/L, hemoglobin = 9 g/dl or 5.59 mmol/l
- •7.Patients not receiving therapeutic anticoagulation must have an INR < 1.5 ULN and aPTT < 1.5 ULN within 7 days prior to enrollment. The use of full dose anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least two weeks at the time of enrollment.
- •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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •1.Treatment with any other investigational agent 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 (oral contraceptives, intrauterine device, barrier method in conjunction with spermicidal jelly, or surgically sterile) during treatment and for 6 months after the end of treatment.
- •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. Note: a negative test has to be reconfirmed by a urine test, should the 7-day window be exceeded.
- •8.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).
- •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 (e.g., pneumonitis or pulmonary fibrosis) 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 (= 12 months before treatment start), 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: aflibercept, 5-FU, folinic acid/ leucovorin, 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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