Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites - Full Text View

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 Procedure: hyperthermia treatment Procedure: laparoscopic surgery	Phase II

MedlinePlus related topics:

Cancer Fever

ChemIDplus related topics:

Mitomycin Mitomycins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label

Official Title:	Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Prevention of malignant recurrence at 4 weeks after treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life after treatment [ Designated as safety issue: No ]
Comparison of serum vascular endothelial growth factor (VEGF) levels prior to treatment and at 4 weeks post treatment [ Designated as safety issue: No ]

Study Start Date:

August 2004

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.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Performance status

ECOG 0-3

Life expectancy

Not specified

Hematopoietic

WBC ≥ 3,000/mm^3
Platelet count ≥ 70,000/mm^3

Hepatic

Bilirubin ≤ 2.0 mg/dL

Renal

See Disease Characteristics
Creatinine ≤ 1.5 mg/dL

Cardiovascular

See Disease Characteristics

Other

Not pregnant or nursing
Negative pregnancy test
No dense intraabdominal adhesions limiting laparoscopy

PRIOR CONCURRENT THERAPY:

Chemotherapy

No prior peritoneal chemotherapy

Contacts and Locations

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

National Cancer Institute (NCI)

Investigators


Study Chair:	Todd M. Tuttle, MD	Masonic Cancer Center, University of Minnesota

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000450848, UMN-2004LS043
First Received:	December 14, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00265863
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

malignant ascites

Study placed in the following topic categories:

Fever

Ascites

Mitomycin

Neoplasm Metastasis

Mitomycins

Additional relevant MeSH terms:

Neoplasms

Neoplastic Processes

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Antibiotics, Antineoplastic

Alkylating Agents

Nucleic Acid Synthesis Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00265863