Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases – a phase II study

Lab values

• Presence of extensive systemic metastases that are deemed to be the dominant factor determining prognosis in terms of life expectancy and performance status [e.g. no imminent threat of impaired organ functioning due to the presence of systemic metastases]); - Prior cytoreductive surgery; - Prior palliative systemic therapy for colorectal cancer; - Prior neo-adjuvant/adjuvant systemic therapy for colorectal cancer within the last 6 months; - Homozygous UGT1A1*28 genotype; - Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency - Microsatellite instable (MSI) primary tumor - Inadequate organ functions, defined as an haemoglobin of <5 mmol/L, an absolute neutrophil count of <1.5 x 109/L, platelet count of <100 x 109/L, serum creatinine of >1.5 x ULN, creatinine clearance of <30 ml/min, Bilirubin > 2x ULN and liver transaminases of >5 x ULN.

• Histologically confirmed colorectal cancer; - Radiologically and clinically or pathologically confirmed unresectable colorectal peritoneal metastases (e.g. PCI >20, extensive small bowel involvement, unresectable disease due to anatomical location); - WHO performance score of 0-1 with a life expectancy of >3 months; - Aged 18 years or older; - Written informed consent.