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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(Withdrawn due to slow accrual)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
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Drug: mitomycin C
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Prevention of malignant recurrence [ Time Frame: Week 4 after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: August 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with Malignant Ascites
Patients meeting protocol criteria enrolled with malignant ascites.
Drug: mitomycin C
Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.
Other Name: MTC

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265863

Locations
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Study Chair: Todd M. Tuttle, MD Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
No publications provided

Responsible Party: Todd Tuttle, MD, Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00265863     History of Changes
Other Study ID Numbers: 2004LS043
Study First Received: December 14, 2005
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:
malignant ascites

Additional relevant MeSH terms:
Ascites
Fever
Neoplasm Metastasis
Body Temperature Changes
Neoplasms
Neoplastic Processes
Pathologic Processes
Signs and Symptoms
Mitomycin
Mitomycins
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014