EUCTR2008-004706-14-FR进行中（未招募）1 期
A randomized, open-label, controlled, multi-center Phase II study to evaluate the efficacy and safety of adecatumumab alone or sequentially to FOLFOX relative to FOLFOX after R0 resection of colorectal liver metastases
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
- Micromet AG
- 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. Histopathologically confirmed complete resection (R0) of liver metastasis(es) from colorectal adenocarcinoma (additional confirmation by CT scan at treatment start)
- •2. Age =18 years
- •3. ECOG performance status = 2
- •4. Ability to understand and willingness to sign a written informed consent.
- •The following eligibility criteria must be fulfilled before the patient can be treated with study medication:
- •1. CT confirmation of complete resection (R0) of liver metastasis(es) (and histopathological confirmation of tumor-free margin)
- •2. Organ or bone marrow function at time of treatment start as defined below:
- •a.WBC > 3 Gpt/l (3x109/L, 3000/mm3)
- •b.Platelet count > 100 Gpt/l (100x109/L, 100,000/mm³)
- •c.Creatinine clearance = 50 ml/min (calculated e.g. according to MDRD)
- •d.Serum bilirubin < 2 x upper limit of normal (ULN)
- •e.AST (SGOT)/ALT (SGPT) = 5 x upper limit of normal (ULN)
- •f.Serum lipase < upper limit of normal (ULN)
- •g. Neutrophils > 2 Gpt/l (2x109/l, 2000/mm³)
- •3. Blood coagulation at time of treatment start as defined below:
- •a.INR < 1.5 x upper limit of normal
- •b.PTT < 1.5 x upper limit of normal(sec)
- •4. Investigator’s discretion that the clinical condition of the patient allows start of treatment
- •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. Extra-hepatic distant metastases or locally recurrent disease at time of enrolment
- •2. Neoadjuvant chemotherapy for liver metastases prior to surgery
- •3. Any anticancer chemotherapy within 4 weeks prior to study entry
- •4. Start of Oxaliplatin-based chemotherapy within 9 months prior to study entry
- •5. Any biological anticancer therapy or immunotherapy within 4 weeks prior to study entry
- •6. Any radiotherapy or radio frequency ablation (RFA) to the liver prior to surgery
- •7. Treatment with any investigational product within a time range of 4-5 half-lives (t½) prior to study entry
- •8. Acute or chronic pancreatitis or history of alcohol induced pancreatitis
- •9. Liver cirrhosis, acute hepatitis or chronic hepatic disease
- •10. Any unresolved complications from surgery
- •11. Persistent neuropathy
- •12. History of other malignancy within 5 years prior to study start, with the exception of basal cell carcinoma of the skin, carcinoma in situ of the cervix and Ductal Carcinoma in Situ (DCIS)
- •13. History of inflammatory bowel disease
- •14. Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
- •15. Use of immune-suppressive agents such as the regular use of systemic corticosteroids
- •16. HIV positivity
- •17. Known hypersensitivity or intolerability to immunoglobulins in general, other recombinant human or humanized antibodies, Folinic Acid, 5-Fluorouracil, Oxaliplatin or a component of the study drug formulations, known dihydropyrimidine dehydrogenase (DPD) deficiency
- •18. Pregnant or nursing women
- •19. Women of childbearing potential or male patients not willing to use an effective form of contraception during treatment phase of the study and at least 6 months thereafter
- •20. Not willing or incapable to comply with all study visits and assessments
- •21. Placed into an institution due to juridical or regulatory ruling
- •22. Vaccination with live vaccines (e.g. yellow fever)
- •23. Concomitant treatment with phenytoin
研究者
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