metastatic colorectal cancer (mCRC) MedDRA version: 14.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Erbitux® 5mg/ml concentrate for solution for infusion
Product Name: Cetuximab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923-56-4
Current Spon
Sponsors
Universitätsmedizin Mainz (vertreten durch den wissenschaftlichen Vorstand)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically-confirmed metastatic colorectal cancer (primary tumor or metastasis) 2. Confirmation of KRAS wildtyp status 3. Confirmation of EGFR-Expression in the tumor 4. Stadium IV 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 6. Qualified for an application of FOLFIRI + Cetuximab treatment 7. Signed patient informed consent form 8. Of either gender and aged 18 years or more 9. Estimated lifespan more than 3 months 10. Measurable disease according to RECIST 1.1 guidelines. The evaluation has to be max. 4 weeks. 11. Effective and adequate contraceptive precautions of man or woman in a childbearing potential age (double barrier method) 12. Leucocytes >= 3,0 x 10^9/L with neutrophils >= 1,5 x 10^9/L, thrombocytes >= 100 x 10^9/L, haemoglobin >=5,6 mmol/L 13. Serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 165
Exclusion criteria
Exclusion criteria: 1. KRAS-gene mutation 2. Confirmation of non-EGFR-Expression 3. Prior treatment with an EGRF-receptor inhibitor 4. Prior chemotherapy of the mCRC, except (neo-)adjuvant therapy, which had to be ended min. 6 months before recruitment 5. Experimental treatment medication within 30 days before recruitment 6. Known hypersensitivity against components of the chemotherapy, Cetuximab, Doxycyclin, Reconval K1 or Dermatop 7. Rosacea 8. Other chronic dermal diseases with development of papula or pustule 9. Known lung fibrosis or interstitial pneumonitis 10. Pregnancy or breast feeding 11. Brain metastasis 12. Clinical relevant coronary heart disease, myocardial infarction within the last 12 months or high risk of uncontrollable arrhythmia 13. Acute or subacute ileus or chronic colon-inflamation or chronic diarrhea 14. Symptomatic peritoneal carcinomatosis 15. Serious, non-healing wounds, ulcera or bone fractures 16. Uncontrollable arterial hypertension 17. Therapeutic anticoagulation (e.g. therapy with marcumar) 18. Known dihydropyrimidine dehydrogenase deficiency 19. Gilbert-Meulengracht-syndrome 20. Other malignant tumours less than five years old. Exceptions include basocellular carcinoma, in situ cancer of the cervix of the uterus, if they are curative treated. 21. Known abuse of narcotic drugs or alcohol 22. Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures. 23. Any significant concomitant disease that excludes the participation to the study 24. Missing or limited juristic contractual capability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the progression free survival (one year) of patients with treatment of FOLFIRI and cetuximab, combined with an regular dermal prophylaxis.;Secondary Objective: 1. Development of acneforme follicular exanthema >= grade 2 2. Duration untill development of acneforme follicular exanthema >= grade 2 3. Development of paronychia 4. Development skin fissure (hand and foot) 5. Objecitve remission according RECIST 1.1 6. Rate of secondary resections of metastasis of liver with a curative approach 7. Assessment of safety and tolerability 8. Overall survival 9. Progression free survival;Primary end point(s): Progression-free survival (PFS) rate at 1 year The primary end point is the analysis of the number of patients, who are treated with FOLFIRI + Cetuximab for mCRC and which are still without any progression after one year. ;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Development of acneforme follicular exanthema >= grade 2 2. Duration untill development of acneforme follicular exanthema >= grade 2 3. Development of paronychia 4. Development skin fissure (hand and foot) 5. Objecitve remission according RECIST 1.1 6. Rate of secondary resections of metastasis of liver with a curative approach 7. Assessment of safety and tolerability 8. Overall survival 9. Progression free survival;Timepoint(s) of evaluation of this end point: until end of study/treatment | — |
Countries
Germany
Contacts
Public ContactClinical Research Organisation
iOMEDICO AG
Outcome results
None listed