Combining intraperitoneal irinotecan with FOLFOX and bevacizumab for colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the feasibility and safety of adding intraperitoneal irinotecan to palliative systemic therapy for patients with unresectable colorectal peritoneal metastases. It aims to evaluate overall survival and progression-free survival, as well as assess the toxicity profile and patient-reported outcomes. Participants will receive a combination of intraperitoneal irinotecan, modified FOLFOX4, and bevacizumab in a single-arm, open-label design. The study will also analyze pharmacokinetics and tumor response during treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Catharina Hospital
  Eindhoven, Netherlands Recruiting
• Erasmus Medical Centre
  Rotterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Pim Burger, MD, PhD
• Email: pim.burger@catharinaziekenhuis.nl
• Phone: 0031402397150

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.