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Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites

Phase 2
18 Years
Not Enrolling
Metastatic Cancer

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Trial Information

Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites



- Determine the effectiveness of laparoscopic hyperthermic perfusion of mitomycin C in
preventing relapse at 4 weeks post-treatment in patients with malignant ascites.


- Determine any improvement in the quality of life of patients treated with this

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:


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:


Principal Investigator

Todd M. Tuttle, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

August 2004

Completion Date:

August 2005

Related Keywords:

  • Metastatic Cancer
  • malignant ascites
  • Ascites
  • Fever
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



University of Minnesota Cancer CenterMinneapolis, Minnesota  55455