Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites

University of Minnesota (UMN)

Status and phase: Terminated; Phase 2

Conditions: Metastatic Cancer

Treatments: Drug: mitomycin C

Study type: Interventional

Funder types: Other

Identifiers

NCT00265863

2004LS043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Patients with Malignant Ascites

Experimental group

Description:

Patients meeting protocol criteria enrolled with malignant ascites.

Treatment:

Drug: mitomycin C