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(Withdrawn due to slow accrual)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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 14, 2005

Last Updated Date

November 6, 2012

Start Date ^ICMJE

August 2004

Primary Completion Date

August 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00265863 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Cancer

Intervention ^ICMJE

Drug: mitomycin C

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

Other Name: MTC

Study Arm (s)

Experimental: Patients with Malignant Ascites

Patients meeting protocol criteria enrolled with malignant ascites.

Intervention: Drug: mitomycin C

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

August 2005

Primary Completion Date

August 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00265863

Other Study ID Numbers ^ICMJE

2004LS043

Has Data Monitoring Committee

Yes

Responsible Party

Todd Tuttle, MD, Masonic Cancer Center, University of Minnesota

Study Sponsor ^ICMJE

Masonic Cancer Center, University of Minnesota

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Todd M. Tuttle, MD

Masonic Cancer Center, University of Minnesota

Information Provided By

Masonic Cancer Center, University of Minnesota

Verification Date

November 2012

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

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