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
- 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose of IP oxaliplatin with systemic intravenous bevacizumab and oral capecitabine after surgical debulking and peritoneal scan documenting functional of intraperitoneal ports in patients with peritoneal carcinomatosis
6 months
Yes
Benjamin Tan, M.D.
Principal Investigator
Washington University School of Medicine
United States: Institutional Review Board
10-0136 / 201107017
NCT01061515
October 2011
January 2019
Name | Location |
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Washington University School of Medicine | Saint Louis, Missouri 63110 |