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

Metastatic Cancer Clinical Trial

Official title:

Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00265863
• Other study ID #: 2004LS043
• Status: Terminated
• Phase: Phase 2
• First received: December 14, 2005
• Last updated: November 27, 2017
• Start date: August 2004
• Est. completion date: August 2005

Study information

• Verified date: November 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Fever
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• mitomycin C
Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.

Locations

Country	Name	City	State
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of malignant recurrence		Week 4 after treatment
Secondary	Quality of life after treatment		Week 4 after treatment
Secondary	Comparison of serum vascular endothelial growth factor (VEGF) levels		Pretreatment and Week 4 after treatment