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

Phase 2

Terminated

• Conditions: Metastatic Cancer
• Interventions: Drug: mitomycin C

• Registration Number: NCT00265863
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2005-12-14
• Study First Submitted QC: 2005-12-14
• Study First Posted: 2005-12-15
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Malignant Ascites	mitomycin C	Patients meeting protocol criteria enrolled with malignant ascites.

Primary Outcome Measures

Name	Time	Method
Prevention of malignant recurrence	Week 4 after treatment

Secondary Outcome Measures

Name	Time	Method
Quality of life after treatment	Week 4 after treatment
Comparison of serum vascular endothelial growth factor (VEGF) levels	Pretreatment and Week 4 after treatment

Trial Locations

Locations (1)

University of Minnesota Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States