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

Phase 2

Terminated

Interventions: Procedure: Surgical debulking with peritonectomy
Drug: Intraperitoneal 5FU
Drug: FOLFOX

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Peritonectomy + IP5FU + FOLFOX	Intraperitoneal 5FU	* Surgical debulking with peritonectomy * IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles. * FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at 2400 mg/m\^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.
Peritonectomy + IP5FU + FOLFOX	Surgical debulking with peritonectomy	* Surgical debulking with peritonectomy * IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles. * FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at 2400 mg/m\^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.
Peritonectomy + IP5FU + FOLFOX	FOLFOX	* Surgical debulking with peritonectomy * IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles. * FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at 2400 mg/m\^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events	30 days after end of treatment

Secondary Outcome Measures

Name	Time	Method
Progression Rate	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.
Progression-free Survival	Median follow-up was 32 months
Number of Participants Who Experience Surgical Complications Associated With This Regimen	Median follow-up was 32 months
Overall Survival	Median follow-up was 32 months