Response monitoring with special chemotherapie (monoclonal antibody) in metastatic colorectal cancer

Phase 1

Conditions: metastatic colorectal cancer
MedDRA version: 16.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2009-013279-23-DE

Lead Sponsor: niversity Hospital of Heidelberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 35

Inclusion Criteria

•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

Exclusion Criteria

•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.