Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites
Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized study.
Patients undergo laparoscopic surgery to remove ascitic fluid and any intraabdominal adhesions and to place 2 inflow and 2 outflow catheters. Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.
Quality of life is assessed at study entry and at 4 weeks.
After completion of study treatment, patients are followed periodically for 2 years.
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:
Must have undergone at least 1 prior paracentesis procedure
No ascites caused by any of the following conditions:
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: