FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema

Subjects with metastatic colorectal cancer and confirmed KRAS-wildtype status in 1st line therapy will be included in this phase IV-study. Subject will receive a regimen of FOLFIRI in combination with Cetuximab every two weeks during study treatment phase. Treatment continues until * disease progression * complete response * development of status of operability * an uncontrollable exanthema grade 3 or 4 or * intolerable toxicity is diagnosed. After study discontinuation or end of treatment, respectively, patients will be followed up until the the last patient was treated for 12 months and has completed the 36-months follow up phase. Tumor response will be evaluated (according to RECIST 1.1) every 12 weeks and at the end of study treatment

Age

18–any

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

Histologically-confirmed metastatic colorectal cancer (primary tumor or metastasis)
Confirmation of KRAS wildtype status
Confirmation of EGFR-Expression in the tumor
Stadium IV
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Qualified for an application of FOLFIRI + Cetuximab treatment
Signed patient informed consent form
Of either gender and aged 18 years or more
Estimated lifespan more than 3 months
Measurable disease according to RECIST 1.1 guidelines. The evaluation has to be max. 4 weeks
Effective and adequate contraceptive precautions of man or woman in a childbearing potential age (double barrier method)
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
Serum bilirubin ≤ 1,5 x ULN (upper limit of normal)
ALAT and ASAT ≤ 2,5 x ULN; if metastasis in liver, than ALAT and ASAT ≤ 5 x ULN
Serum creatinin ≤ 1,5 x ULN
If applicable a prior operation has to be min. 4 weeks ago, biopsy more than 1 week until initiation of treatment. Wounds of operations had to be completely cured
No toxicity of prior treatments

You may not be if

KRAS-gene mutation
Confirmation of non-EGFR-Expression
Prior treatment with an EGRF-receptor inhibitor
Prior chemotherapy of the mCRC, except (neo-)adjuvant therapy, which had to be ended min. 6 months before recruitment
Experimental treatment medication within 30 days before recruitment
Known hypersensitivity against components of the chemotherapy, cetuximab, doxycycline, Reconval K1 or Dermatop
Rosacea
Other chronic dermal diseases with development of papula or pustule
Known lung fibrosis or interstitial pneumonitis or interstitial lung diseases
keratitis, ulcerative keratitis or severe form of dry eye
Pregnancy or breast feeding
Brain metastasis
Clinical relevant coronary heart disease, myocardial infarction within the last 12 months or high risk of uncontrollable arrhythmia
Acute or subacute ileus or chronic colon-inflammation or chronic diarrhea
Symptomatic peritoneal carcinomatosis
Serious, non-healing wounds, ulcera or bone fractures
Uncontrollable arterial hypertension
Therapeutic anticoagulation (e.g. therapy with marcumar)
Known dihydropyrimidine dehydrogenase deficiency
Gilbert-Meulengracht-syndrome
Other malignant tumours less than five years old. Exceptions include basocellular carcinoma or an in situ cancer of the cervix uteri if they are curative treated as well as an untreated, locally confined, asymptotic "low risk" (indolent) prostata carcinoma (Stage T ≤ T1-2a, PSA \< 15 ng/ml, Gleason-Score ≤ 6 ).
Known abuse of narcotic drugs or alcohol
Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
Any significant concomitant disease that excludes the participation to the study
Missing or limited juristic contractual capability

What this study is about