Intraperitoneal Irinotecan With Concomitant FOLFOX and Bevacizumab

Last updated: August 15, 2023
Sponsor: Catharina Ziekenhuis Eindhoven
Overall Status: Active - Recruiting

Phase

2

Condition

Colorectal Cancer

Cancer

Rectal Cancer

Treatment

Irinotecan

FOLFOX regimen

Bevacizumab

Clinical Study ID

NCT06003998
NL81672.100.22
  • Ages > 18
  • All Genders

Study Summary

The rationale of the current study is that the addition of intraperitoneal irinotecan (75 mg) to palliative systemic therapy is feasible and safe, and might result in an increased overall and progression free survival in patients with unresectable colorectal peritoneal metastases. The primary objectives are to explore the overall survival for the addition of intraperitoneal irinotecan (75 mg) to palliative systemic therapy in patients with unresectable colorectal peritoneal metastases. Secondary objectives are to assess the progression-free survival, toxicity profile, patient reported outcomes, costs, tumor response during trial treatment, and the systemic and intraperitoneal pharmacokinetics of irinotecan and SN-38. This is a single-arm, open-label, phase II study and patients will receive intraperitoneal irinotecan (75 mg) in combination with modified FOLFOX4 + bevacizumab.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed colorectal cancer;
  • Radiologically and clinically or pathologically confirmed unresectable colorectalperitoneal metastases (e.g. PCI >20, extensive small bowel involvement, unresectabledisease 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

Exclusion Criteria:

  • Presence of extensive systemic metastases that are deemed to be the dominant factordetermining prognosis in terms of life expectancy and performance status [e.g. noimminent threat of impaired organ functioning due to the presence of systemicmetastases]);
  • Prior cytoreductive surgery;
  • Prior palliative systemic therapy for colorectal cancer;
  • Prior neo-adjuvant/adjuvant systemic therapy for colorectal cancer within the last 6months;
  • 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, seriousconcomitant disease, severe allergy), as determined by the medical oncologist;
  • Inadequate organ functions, defined as an haemoglobin of <5 mmol/L, an absoluteneutrophil 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 livertransaminases of >5 x ULN.

Study Design

Total Participants: 85
Treatment Group(s): 3
Primary Treatment: Irinotecan
Phase: 2
Study Start date:
December 27, 2022
Estimated Completion Date:
January 01, 2025

Connect with a study center

  • Catharina Hospital

    Eindhoven,
    Netherlands

    Active - Recruiting

  • Erasmus Medical Centre

    Rotterdam,
    Netherlands

    Active - Recruiting

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