Intraperitoneal Irinotecan With Concomitant FOLFOX and Bevacizumab

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.

Timeline

Start

2022-12-27

Primary completion

2025-01-01

Completion

2025-01-01

Publications

• van de Vlasakker VCJ, Guchelaar NAD, van den Heuvel TBM, Lurvink RJ, van Meerten E, Bax RJF, Creemers GM, van Hellemond IEG, Brandt-Kerkhof ARM, Madsen EVE, Nederend J, Koolen SLW, Nienhuijs SW, Kranenburg O, de Hingh IHJT, Verhoef C, Mathijssen RHJ, Burger JWA; Dutch Peritoneal Oncology Group; Dutch Colorectal Cancer Group. Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases: protocol of the multicentre, open-label, phase II, INTERACT-II trial. BMJ Open. 2024 Jan 18;14(1):e077667. doi: 10.1136/bmjopen-2023-077667.

Drugs

Indications