Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma
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.
Interventional
Primary Purpose: Treatment
Robert N. Taub, MD, PhD
Study Chair
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
CDR0000068907
NCT00024271
May 2001
Name | Location |
---|---|
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |