drugset / Trial / NCT05379790

Concomitant Intraperitoneal and Systemic Chemotherapy in Patients With Extensive Peritoneal Carcinomatosis of Gastric Origin

NCT05379790

Phase 1 Completed 20 enrolled Erasmus Medical Center
Non-randomizedSequentialOpen-labelTreatment

Summary

Gastric cancer with peritoneal carcinomatosis has a poor prognosis, with little treatment options available. The current treatment strategy consists of palliative systemic chemotherapy. However, previous research suggests that systemic chemotherapy is less effective against peritoneal carcinomatosis than against metastases that spread hematogenously. Several studies suggested that in patients with peritoneal carcinomatosis, intraperitoneal chemotherapy (IP) may be superior compared to intravenous chemotherapy. Intraperitoneal chemotherapy could lead to higher concentrations of chemotherapy in the peritoneal cavity for a longer period of time, resulting in an increased cumulative exposure to the peritoneal metastases. A few Asian studies have shown promising results with intraperitoneal chemotherapy in patients with peritoneal carcinomatosis of gastric origin. However, intraperitoneal chemotherapy combined with systemic chemotherapy has not been investigated in Western patients with peritoneal carcinomatosis of gastric origin yet. The objective of this trial is to establish the maximum tolerated dose (MTD) of intraperitoneal administration of irinotecan, added to systemic capecitabine/oxaliplatin (CAPOX) in patients with peritoneal carcinomatosis of gastric origin.

Timeline

Start
2022-05-25
Primary completion
2024-11-25
Completion
2025-02-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 50 mg Other
Subject Irinotecan Small molecule 75 mg Other
Subject Irinotecan Small molecule 100 mg Other
Subject Irinotecan Small molecule 150 mg Other
Subject Irinotecan Small molecule 200 mg Other
Subject Irinotecan Small molecule 250 mg Other
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous