EUCTR2009-013279-23-DE
Active, not recruiting
Phase 1
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 sites35 target enrollmentFebruary 2, 2010
Conditionsmetastatic colorectal cancerMedDRA version: 16.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsErbitux
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- metastatic colorectal cancer
- Sponsor
- niversity Hospital of Heidelberg
- Enrollment
- 35
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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