ISRCTN75334801
Completed
Not Applicable
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 sites35 target enrollmentSeptember 4, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic colorectal cancer
- Sponsor
- niversity of Heidelberg (Germany)
- Enrollment
- 35
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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