Status:
TERMINATED
Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 t...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- Prior peritoneal chemotherapy
- Dense intraabdominal adhesions limiting laparoscopy
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00265863
Start Date
August 1 2004
End Date
August 1 2005
Last Update
November 29 2017
Active Locations (1)
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1
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455