Abbreviations
FOLFIRI+CETU
FOLFIRI+BEVA
169
183
Phase:
3
Open label
CRC
KRAS WT
meta
L1
- KRAS-Wildtype statusdc-return- Histologically confirmed adenocarcinoma of the colon or rectum; - Stage IV disease.dc-return- ECOG 0-2; - Patients considered suitable for application of chemotherapy; - Age 18 - 75 years - In- or outpatient treatment - Estimated life expectancy > 3 months; - Measurable index lesion according to RECIST criteria. Evaluation of tumor manifestations ≤ 2 weeks prior to treatment start; - Effective contraception; - Adequate hematologic function: leukocytes ≥ 3000/µl, neutrophils ≥ 1500/µl, platelets ≥ 100.000/µ, and hemoglobin ≥ 9g/dl. - Bilirubin ≤ 1,5x upper limit of normal (ULN); - ALAT and ASAT ≤ 2,5x ULN, in case of liver metastases ≤ 5x ULN; - Serum creatinine ≤ 1,5x ULN; - No operations within 4 weeks prior to treatment start. No cytologic biopsies within 1 week prior to treatment start.
- KRAS-Mutation of the tumordc-return- Prior treatment directed against the epidermal growth factor receptor (EGFR).dc-return- Prior treatment with bevacizumab.dc-return- Prior chemotherapy for colorectal cancer, except for adjuvant chemotherapy dating back > 6 months prior to study entry.dc-return- Experimental medical treatment within 30 days prior to study entry.dc-return- Known hypersensitivity reaction to any study medication.dc-return- Pregnant or breast feeding women (pregnancy needs to be excluded by testing of beta-HCG).dc-return- Known or suspected cerebral metastases.dc-return- Clinically significant coronary heart disease, myocardial infarction within the last 12 months or high risk of uncontrolled arrhythmia.dc-return- Acute or subacute ileus, chronic inflammatory bowel disease or chronic diarrhea.dc-return- Symptomatic peritoneal carcinosis.dc-return- Severe chronic wounds, ulcera or bone fracture.dc-return- Uncontrolled hypertension.dc-return