Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites|
- Prevention of malignant recurrence [ Time Frame: Week 4 after treatment ] [ Designated as safety issue: No ]
- Quality of life after treatment [ Time Frame: Week 4 after treatment ] [ Designated as safety issue: No ]
- Comparison of serum vascular endothelial growth factor (VEGF) levels [ Time Frame: Pretreatment and Week 4 after treatment ] [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
|Study Completion Date:||August 2005|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
Experimental: Patients with Malignant Ascites
Patients meeting protocol criteria enrolled with malignant ascites.
Drug: mitomycin C
Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.
Other Name: MTC
- Determine the effectiveness of laparoscopic hyperthermic perfusion of mitomycin C in preventing relapse at 4 weeks post-treatment in patients with malignant ascites.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265863
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|Study Chair:||Todd M. Tuttle, MD||Masonic Cancer Center, University of Minnesota|