drugset / Trial / NCT01061515

Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab for Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer

NCT01061515

Phase 1 Active not recruiting 21 enrolled Washington University School of Medicine
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is to test escalating doses of intraperitoneal (IP) oxaliplatin in conjunction with systemic bevacizumab and capecitabine in patients with Peritoneal Carcinomatosis (PC) from either appendiceal or colorectal adenocarcinoma that have been adequately cytoreduced and have undergone a peritoneal scan demonstrating patency of at least one of the intraperitoneal ports that were placed at the time of debulking.

Timeline

Start
2011-05-10
Primary completion
2026-09-27
Completion
2026-09-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxaliplatin Small molecule 25 mg/m2 Intrathecal
Subject Oxaliplatin Small molecule 50 mg/m2 Intrathecal
Subject Oxaliplatin Small molecule 65 mg/m2 Intrathecal
Subject Oxaliplatin Small molecule 85 mg/m2 Intrathecal
Subject Oxaliplatin Small molecule 100 mg/m2 Intrathecal
Background Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Background Capecitabine Small molecule Oral

Indications