Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites
This study has been terminated.
(Withdrawn due to slow accrual)
Sponsor:
Masonic Cancer Center, University of Minnesota
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
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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
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 Neoplasms Neoplasms, Second Primary Pathologic Processes Body Temperature Changes Signs and Symptoms Neoplastic Processes Mitomycins |
Mitomycin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents |
ClinicalTrials.gov processed this record on June 17, 2013