Intraperitoneal Irinotecan With Concomitant FOLFOX and Bevacizumab

Launched by CATHARINA ZIEKENHUIS EINDHOVEN · Aug 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with colorectal cancer that has spread to the lining of the abdomen, known as peritoneal metastases. Researchers want to find out if adding a medication called intraperitoneal irinotecan to standard chemotherapy (FOLFOX and bevacizumab) can help patients live longer and improve their quality of life. The trial is currently recruiting patients aged 18 and older who have been diagnosed with colorectal cancer that cannot be surgically removed and have a good performance status, meaning they are able to care for themselves and have a life expectancy of more than three months.

Participants in this study can expect to receive the combination treatment of irinotecan directly into the abdominal cavity along with standard chemotherapy. Throughout the trial, researchers will monitor the effects of the treatment, including any side effects, how well the cancer responds, and the overall health of participants. It's important to note that some people may not qualify for this trial due to specific health conditions or previous treatments. If you or a loved one is considering joining this trial, it’s a great opportunity to potentially access a new treatment that could improve outcomes for patients with this challenging condition.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 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;
• Exclusion Criteria:
• • 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
• • Any contra-indication for the planned chemotherapy (e.g. active infection, serious concomitant disease, severe allergy), as determined by the medical oncologist;
• • 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.