Metastatic Cancer Clinical Trial
Official title:
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
- Determine the effectiveness of laparoscopic hyperthermic perfusion of mitomycin C in
preventing relapse at 4 weeks post-treatment in patients with malignant ascites.
Secondary
- Determine any improvement in the quality of life of patients treated with this
procedure.
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.
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