Combining intraperitoneal irinotecan with FOLFOX and bevacizumab for colorectal cancer

Intraperitoneal Irinotecan With Concomitant FOLFOX and Bevacizumab for Patients With Unresectable Colorectal Peritoneal Metastases

This study is testing whether adding a special chemotherapy directly into the abdomen can help people with advanced colorectal cancer live longer and feel better while receiving other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Catharina Ziekenhuis Eindhoven (Academic / other)
• Drugs / interventions: chemotherapy, bevacizumab
• Locations: 2 sites (Eindhoven and 1 other locations)
• Trial ID: NCT06003998 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed colorectal cancer and unresectable peritoneal metastases.

Not a fit: Patients with extensive systemic metastases or those who have undergone prior cytoreductive surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve overall and progression-free survival for patients with advanced colorectal cancer.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination is being explored in a novel context.

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.

Where this trial is running

Eindhoven and 1 other locations

• Catharina Hospital — Eindhoven, Netherlands (Recruiting)
• Erasmus Medical Centre — Rotterdam, Netherlands (Recruiting)

Study contacts

• Study coordinator: Pim Burger, MD, PhD

Conditions Colorectal Cancer; Peritoneal Metastases; Peritoneal metastases; colorectal cancer; Intraperitoneal; Irinotecan