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

Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00265863

Enrollment

Registered

2005-12-15

Start date

2004-08-31

Completion date

2005-08-31

Last updated

2017-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Cancer

Keywords

malignant ascites

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.

Interventions

DRUGmitomycin C

Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Prevention of malignant recurrence	Week 4 after treatment

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026