Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites

• Status: Terminated
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated chemotherapy drugs, such as mitomycin, may kill more tumor cells.

PURPOSE: This phase II trial is studying how well mitomycin works when given as a hyperthermic peritoneal perfusion in treating patients with malignant ascites.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• Diagnosis of peritoneal metastases and malignant ascites by physical examination, ultrasound, or CT scan

• Not eligible for cytoreductive surgery based on any of the following criteria:

• Metastases outside peritoneal cavity

• Poor performance status

• Unresectable peritoneal disease

• Must have undergone at least 1 prior paracentesis procedure

• No ascites caused by any of the following conditions:

• Cardiac failure

• Nephrotic syndrome

• Pancreatic ascites

• Chylous ascites

• Eastern Cooperative Oncology Group (ECOG) performance status 0-3

• WBC ≥ 3,000/mm^3

• Platelet count ≥ 70,000/mm^3

• Bilirubin ≤ 2.0 mg/dL

• Creatinine ≤ 1.5 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

Exclusion Criteria:

• Prior peritoneal chemotherapy

• Dense intraabdominal adhesions limiting laparoscopy