NCT01061515

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

A Phase I Dose-Escalation Trial of Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab Following Cytoreduction in Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* To determine the maximum tolerated dose of IP oxaliplatin with systemic intravenous bevacizumab and oral capecitabine after adequate surgical debulking and peritoneal scan documenting function of intraperitoneal ports in patients with peritoneal carcinomatosis of appendiceal or colorectal etiology. * To assess the safety and tolerability of repeated delayed intraperitoneal chemotherapy with oxaliplatin and systemic intravenous bevacizumab and oral capecitabine after adequate surgical debulking and peritoneal scan documenting function of intraperitoneal ports in patients with peritoneal carcinomatosis of appendiceal or colorectal etiology. * To describe the progression rate, progression-free survival and overall survival in patients treated with this regimen.

Conditions

• Carcinoma

Interventions

Type	Name	Description
DRUG	Intraperitoneal Oxaliplatin
DRUG	Bevacizumab
DRUG	Capecitabine

Timeline

• Start date: 2011-05-10
• Primary completion: 2026-09-27
• Completion: 2026-09-27
• First posted: 2010-02-03
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study