Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites
18 Years
N/A
Both
Metastatic Cancer
Trial Information
Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Prevention of malignant recurrence
Outcome Time Frame:
Week 4 after treatment
Safety Issue:
No
Principal Investigator
Todd M. Tuttle, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Food and Drug Administration
Study ID:
2004LS043
NCT ID:
NCT00265863
Start Date:
August 2004
Completion Date:
August 2005
Related Keywords:
- Metastatic Cancer
- malignant ascites
- Ascites
- Fever
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
