In vivo response monitoring of treatment with the EGFR-monoclonal-antibody Cetuximab in metastatic colorectal cancer – a single center phase II study - REMOTUX

niversity Hospital of Heidelberg0 个研究点目标入组 35 人开始时间: 2010年2月2日最近更新: 2017年3月13日

适应症

试验速览

暂无简介。

•Histologically confirmed metastatic colorectal cancer
•RAS-wildtype status of the tumor
•No history of therapy with an EGFR targeting agent
•No history of previous chemotherapy for advanced disease
•Measurable tumor lesion with a diameter no smaller than 1.0 cm detected by CT, MRI
•or ultrasound
•For contrast-enhanced ultrasound: metastases no smaller than 2.0 cm
•ECOG-performance status 0 or 1 or Karnofsky performance scale min. 70%
•Life expectancy > 12 weeks
•Age = 18 years
•Adequate hematologic, renal and hepatic function
•Ability of the patient to understand the character and individual consequences of this clinical trial
•Written informed consent (must be available before enrolment in the trial)
•For women and men with childbearing potential adequate double barrier contraception, for women: negative pregnancy test
•Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 19

•Any contraindications for chemotherapy according to the Folfiri regimen
•Non-curatively treated malignancy within the last 5 years
•Uncontrolled or insulin-dependent diabetes mellitus
•Evidence of CNS metastases
•Uncontrolled infection
•Significant cardiac disease (unstable angina pectoris or cardiac symptoms according to NYHA classification III or IV)
•Active serious illness which renders the patient unsuitable for study entry or multiple blood sampling
•Pregnancy and lactation
•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
•Participation in other competing clinical trials or observation period of competing trials, respectively
•No patient will be allowed to enroll in this trial more than once.

发起方

niversity Hospital of Heidelberg