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

This study has been terminated.
(Withdrawn due to slow accrual)
Sponsor:
Information provided by:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00265863
First received: December 14, 2005
Last updated: November 6, 2012
Last verified: November 2012

December 14, 2005
November 6, 2012
August 2004
August 2005   (final data collection date for primary outcome measure)
Prevention of malignant recurrence [ Time Frame: Week 4 after treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00265863 on ClinicalTrials.gov Archive Site
  • Quality of life after treatment [ Time Frame: Week 4 after treatment ] [ Designated as safety issue: No ]
  • Comparison of serum vascular endothelial growth factor (VEGF) levels [ Time Frame: Pretreatment and Week 4 after treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites
Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Cancer
Drug: mitomycin C
Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.
Other Name: MTC
Experimental: Patients with Malignant Ascites
Patients meeting protocol criteria enrolled with malignant ascites.
Intervention: Drug: mitomycin C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
August 2005
August 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00265863
2004LS043
Yes
Todd Tuttle, MD, Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
Not Provided
Study Chair: Todd M. Tuttle, MD Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP