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

Phase 2

Recruiting

• Conditions: Colorectal Cancer with metastasis in the peritoneum; Peritoneal carcinomatosis of colorectal origin; 10034652; 10017991

• Registration Number: NL-OMON56200
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 85

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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified