Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites
| Status: | Terminated |
|---|---|
| Conditions: | Cancer, Cancer, Infectious Disease, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/1/2017 |
| Start Date: | August 2004 |
| End Date: | August 2005 |
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
