Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites
Stopped early · Phase 2
Conditions studied: Metastatic Cancer
In brief
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.
Key facts
- Study ID
- NCT00265863
- Run by
- Masonic Cancer Center, University of Minnesota
- People needed
- 1
- Starts
- 2004-08-01
- Expected to finish
- 2005-08-01
- Last updated by the study team
- 2017-11-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Prior peritoneal chemotherapy
- Dense intraabdominal adhesions limiting laparoscopy
Where it is running
- University of Minnesota Cancer Center — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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