Clinical trial NCT00265863: Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites
Official title: Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Cancer
Keywords: malignant ascites
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2005-12-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevention of malignant recurrence
timeFrame: Week 4 after treatment
Secondary outcomes:
measure: Quality of life after treatment
timeFrame: Week 4 after treatment
measure: Comparison of serum vascular endothelial growth factor (VEGF) levels
timeFrame: Pretreatment and Week 4 after treatment
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Todd M. Tuttle, MD
role: STUDY_CHAIR
References: