Malignant Mesothelioma Clinical Trial
Official title:
Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Giving the drugs directly into the tumor after surgery and
combining them with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy, and
radiation therapy in treating patients who have peritoneal cancer.
OBJECTIVES:
- Determine the response rate, duration of response, and duration of survival of patients
with peritoneal mesothelioma treated with surgery, intraperitoneal chemotherapy, and
whole abdominal radiotherapy.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients undergo initial surgery, including total omentectomy and excision of gross
disease. Approximately 3-4 weeks after surgery, patients receive intraperitoneal (IP)
chemotherapy consisting of doxorubicin IP over 2 hours once weekly on weeks 1, 4, 7, and 10
and cisplatin IP and gemcitabine IP once weekly on weeks 2, 5, 8, and 11. Patients also
receive interferon gamma IP once weekly on weeks 13-16.
At approximately week 18-20, patients undergo second-look surgery. Patients with no gross
disease receive hyperthermia mitomycin IP and cisplatin IP over 90 minutes.
Approximately 2-4 weeks after second-look surgery, patients undergo radiotherapy 5 days a
week for 5-7 weeks. Treatment continues in the absence of disease progression or
unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then
annually for 5 years.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
;
Primary Purpose: Treatment
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