EUCTR2010-019885-10-DE进行中（未招募）1 期
on-randomized phase-IV-study to investigate the efficacy of FOLFIRI in combination with cetuximab in the first-line treatment of metastatic colorectal cancer inculding a regular dermal prophylaxis to prevent acneforme follicular exanthema - Dermatux
niversitätsmedizin Mainz (vertreten durch den wissenschaftlichen Vorstand)0 个研究点开始时间: 2010年10月15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
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. Histologically-confirmed metastatic colorectal cancer (primary tumor or metastasis)
- •2. Confirmation of KRAS wildtyp status
- •3. Confirmation of EGFR-Expression in the tumor
- •4. Stadium IV
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •6. Qualified for an application of FOLFIRI + Cetuximab treatment
- •7. Signed patient informed consent form
- •8. Of either gender and aged 18 years or more
- •9. Estimated lifespan more than 3 months
- •10. Measurable disease according to RECIST 1.1 guidelines. The evaluation has to be max. 4 weeks.
- •11. Effective and adequate contraceptive precautions of man or woman in a childbearing potential age (double barrier method)
- •12. Leucocytes >= 3,0 x 10^9/L with neutrophils >= 1,5 x 10^9/L, thrombocytes >= 100 x 10^9/L, haemoglobin >=5,6 mmol/L
- •13. Serum bilirubin <= 1,5 x ULN (upper limit of normal)
- •14. ALAT and ASAT <= 2,5 x ULN; if metastasis in liver, than ALAT and ASAT <= 5 x ULN
- •15. Serum creatinin <= 1,5 x ULN
- •16. If applicable a prior operation has to be min. 4 weeks ago, biopsy more than 1 week until initiation of treatment. Wounds of operations had to be completely cured.
- •17. No toxicity of prior treatments
- •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 165
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 165
排除标准
- •1. KRAS-gene mutation
- •2. Confirmation of non-EGFR-Expression
- •3. Prior treatment with an EGRF-receptor inhibitor
- •4. Prior chemotherapy of the mCRC, except (neo-)adjuvant therapy, which had to be ended min. 6 months before recruitment
- •5. Experimental treatment medication within 30 days before recruitment
- •6. Known hypersensitivity against components of the chemotherapy, Cetuximab, Doxycyclin, Reconval K1 or Dermatop
- •7. Rosacea
- •8. Other chronic dermal diseases with development of papula or pustule
- •9. Known lung fibrosis or interstitial pneumonitis
- •10. Pregnancy or breast feeding
- •11. Brain metastasis
- •12. Clinical relevant coronary heart disease, myocardial infarction within the last 12 months or high risk of uncontrollable arrhythmia
- •13. Acute or subacute ileus or chronic colon-inflamation or chronic diarrhea
- •14. Symptomatic peritoneal carcinomatosis
- •15. Serious, non-healing wounds, ulcera or bone fractures
- •16. Uncontrollable arterial hypertension
- •17. Therapeutic anticoagulation (e.g. therapy with marcumar)
- •18. Known dihydropyrimidine dehydrogenase deficiency
- •19. Gilbert-Meulengracht-syndrome
- •20. Other malignant tumours less than five years old. Exceptions include basocellular carcinoma, in situ cancer of the cervix of the uterus, if they are curative treated.
- •21. Known abuse of narcotic drugs or alcohol
- •22. Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.
- •23. Any significant concomitant disease that excludes the participation to the study
- •24. Missing or limited juristic contractual capability
研究者
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