EUCTR2007-007863-26-FR进行中（未招募）1 期
A multicentre randomized phase II study to assess the safety and resectability in patients with primarily unresectable liver metastases secondary to colorectal cancer receiving treatment with 5-FU, leucovorin, oxaliplatin and bevacizumab with or without irinotecan as first line treatment
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •- Histologically confirmed carcinoma of the colon and/or rectum with evidence of liver
- •metastases (Note: if time interval from last histological diagnosis to enrolment
- •exceeds 3 years, new histological confirmation of metastatic disease is required).
- •- Male and female patients aged greater than or equal to 18 years and less than or
- •equal to 70 years.
- •- ECOG performance score of 0 or 1.
- •- Written informed consent.
- •- General condition considered feasible for major abdominal surgery after first line
- •- Unresectability of hepatic metastases at randomization (at least one of the
- •following criteria):
- •- No upfront R0 resection of all hepatic lesions possible
- •- Less than 30% estimated residual liver after resection
- •- Disease in contact with major vessels of the remnant liver.
- •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
- •- Diagnosis of metastatic disease more than 3 months prior to study entry.
- •- Evidence of extrahepatic metastatic disease (excluded by FDG-PET).
- •- Evidence of diffuse peritoneal carcinosis or involvement of celiac lymph nodes.
- •- Prior systemic or local treatment of metastatic disease.
- •- Prior adjuvant or neo-adjuvant chemotherapy/radiotherapy completed less than 6
- •months prior to study entry.
- •- Concomitant use with St John's Wort.
- •- Treatment with any other investigational agent, or participation in another clinical
- •trial within 30 days prior to entering this study.
- •- Current or recent (within 10 days of first dose of study treatment) chronic use of
- •aspirin (> 325 mg/day) or clopidrogel (> 75 mg/day).
- •- 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.
- •- History or evidence upon physical/neurological examination of CNS disease
- •(unrelated to cancer) (unless adequately treated with standard medical therapy)
- •e.g. uncontrolled seizures.
- •- 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
- •- Clinically significant cardiovascular disease, for example CVA, myocardial infarction
- •(less than or equal to 12 months before treatment start), unstable angina, New
- •York Heart Association (NYHA) greater than or equal to Class II, congestive heart
- •failure (CHF), arrhythmia requiring medication, or uncontrolled hypertension.
- •- Evidence of bleeding diathesis or coagulopathy.
- •- Known hypersensitivity to any of the study drugs.
- •- Serious, non-healing wound, ulcer or bone fracture.
- •- Major surgical procedure, open biopsy or significant traumatic injury within 28 days
- •prior to treatment.
- •- Central venous access device (CVAD) for chemotherapy administration inserted
- •within 2 days prior to study treatment start.
- •- 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.
- •- Life expectancy less than 3 months.
- •- Inability or unwillingness to comply with the protocol.
- •- Inadequate haematological function: ANC < 1.5 x 1000000000/L; platelets < 100 x
- •1000000000/L, Hemoglobin (Hb) < 9 g/dL (may be transfused prior to enrolment).
- •- INR >1.5 within 7 days prior to starting study treatment. aPTT > 1.5 x ULN within 7
- •days prior to starting study treatment.
- •- Liver function: Serum bilirubin > 1.5 x ULN; alkaline phosphatase and
- •transaminases > 5 x ULN (liver metastases).
- •- Serum Creatinine > 1.5 x ULN.
- •- Urine dipstick for proteinuria grater than or equal to 2+. If urine dipstick is greater
- •than or equal to 2+, 24-hour urine must demonstrate less than or equal to 1 g of
- •protein in 24 hours for patient to be eligible.
- •- Pregnancy or lactation.
- •- Positive serum pregnancy test within 7 days of starting study treatment in
- •pre-menopausal women and women < 2 years after the onset of menopause.
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