NCT06003998

Intraperitoneal Irinotecan With Concomitant FOLFOX and Bevacizumab

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Catharina Ziekenhuis Eindhoven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Peritoneal Metastases

Interventions

Type	Name	Description
DRUG	Irinotecan	2 weekly IP irinotecan (max 12 cycles), dose 75 mg flat dose
DRUG	FOLFOX regimen	FOLFOX-4 regimens consist of 85 mg/m2 oxaliplatin plus 200 mg/m2 LV and 5-FU 400 mg/m2 bolus on day 1 followed by 1600 mg/m2 5-FU as a 46-h infusion
DRUG	Bevacizumab	Bevacizumab according to standard of care

Timeline

• Start date: 2022-12-27
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2023-08-22
• Last updated: 2023-08-22

Locations

2 sites across 1 country: Netherlands