Clinical Trial: A Phase II Study of Surgical Debulking With Peritonectomy and Biweekly Intraperitoneal 5FU With Systemic Oxaliplatin/5FU/Leucovorin in Patients With Pseudomyxoma Peritonei or Peritoneal Carcinomatosis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Study of Surgical Debulking With Peritonectomy and Biweekly Intraperitoneal 5FU With Systemic Oxaliplatin/5FU/Leucovorin in Patients With Pseudomyxoma Peritonei

Brief Summary: This study prospectively evaluates a multidisciplinary approach to patients with intraperitoneal carcinomatosis at Washington University. Patients with peritoneal carcinomatosis or pseudomyxoma peritonei will undergo debulking surgery with peritonectomy and placement of adhesive barrier film followed by repeated delayed intraperitoneal chemotherapy with 5FU with systemic oxaliplatin-based chemotherapy on a biweekly schedule. A retrospective review of patients treated in a similar manner at our institution showed good tolerance and efficacy. This formal Phase II study is planned to determine the safety, toxicities and survival of patients with peritoneal carcinomatosis and pseudomyxoma peritonei treated with this regimen.

Detailed Summary:
Sponsor: Washington University School of Medicine

Current Primary Outcome: Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events [ Time Frame: 30 days after end of treatment ]

Original Primary Outcome: To assess the safety and tolerability of the planned treatment regimen

Current Secondary Outcome:

  • Progression Rate [ Time Frame: Median follow-up was 32 months ]
    -Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
  • Number of Participants Who Experience Surgical Complications Associated With This Regimen [ Time Frame: Median follow-up was 32 months ]
  • Progression-free Survival [ Time Frame: Median follow-up was 32 months ]
  • Overall Survival [ Time Frame: Median follow-up was 32 months ]


Original Secondary Outcome:

Information By: Washington University School of Medicine

Dates:
Date Received: July 14, 2006
Date Started: May 2006
Date Completion:
Last Updated: October 19, 2016
Last Verified: October 2016