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

NCT00265863 | Terminated Phase 2 DMC

• 1 other identifier: 2004LS043
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Cancer

Keywords

malignant ascites

Outcome Measures

Primary Outcomes (1)

• Prevention of malignant recurrence

  Week 4 after treatment

Secondary Outcomes (2)

• Quality of life after treatment

  Week 4 after treatment

• Comparison of serum vascular endothelial growth factor (VEGF) levels

  Pretreatment and Week 4 after treatment

Study Arms (1)

Patients with Malignant Ascites

EXPERIMENTAL

Patients meeting protocol criteria enrolled with malignant ascites.

Drug: mitomycin C

Interventions

mitomycin C DRUG

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

Also known as: MTC

Patients with Malignant Ascites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior peritoneal chemotherapy
• Dense intraabdominal adhesions limiting laparoscopy

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Todd M. Tuttle, MD

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2005
• First Posted: December 15, 2005
• Study Start: August 1, 2004
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (1)