In vivo response monitoring of treatment with the epidermal growth factor receptor (EGFR) monoclonal antibody cetuximab in metastatic colorectal cancer: a single centre phase II study

niversity of Heidelberg (Germany)0 个研究点目标入组 35 人开始时间: 2009年9月4日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Histologically confirmed metastatic colorectal cancer
•2. KRAS-wildtype status of the tumour
•3. No history of therapy with an EGFR targeting agent
•4. No history of previous chemotherapy for advanced disease
•5. Measurable tumour lesion with a diameter no smaller than 1.0 cm detected by computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound
•6. For contrast-enhanced ultrasound: metastases no smaller than 2.0 cm detected by ultrasound
•7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 or Karnofsky performance scale minimum 60%
•8. Life expectancy greater than 12 weeks
•9. Age greater than or equal to 18 years, either sex
•10. Adequate haematologic, renal and hepatic function
•11. Ability of the patient to understand the character and individual consequences of this clinical trial
•12. Written informed consent (must be available before enrolment in the trial)
•13. For women and men with childbearing potential adequate double barrier contraception, for women: negative pregnancy test
•14. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

•1. Any contraindications for chemotherapy according to the Folfiri regimen
•2. Non-curatively treated malignancy within the last 5 years
•3. Uncontrolled or insulin-depending diabetes mellitus
•4. Evidence of central nervous system (CNS) metastases
•5. Uncontrolled infection
•6. Significant cardiac disease (unstable angina pectoris or cardia symptoms according to New York Heart Association [NYHA] classification III or IV)
•7. Active serious illness which renders the patient unsuitable for study entrance or multiple blood sampling
•8. Pregnancy and lactation
•9. History of hypersensitivity to cetuximab or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
•10. Participation in other clinical trials or observation period of competing trials, respectively
•11. No patient will be allowed to enrol in this trial more than once

发起方

niversity of Heidelberg (Germany)