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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites

Conditions
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Metastatic Cancer

Intervention / Treatment
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* Drug: mitomycin C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Malignant Ascites<br>Patients meeting protocol criteria enrolled with malignant ascites. | Drug: mitomycin C<br>* Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.<br>* Other names: MTC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of malignant recurrence |  | Week 4 after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life after treatment |  | Week 4 after treatment | 
| Comparison of serum vascular endothelial growth factor (VEGF) levels |  | Pretreatment and Week 4 after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignant ascites