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.
- 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
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.
- Histologically confirmed malignant mesothelioma
- Measurable or evaluable disease
- Ineligible for other high-priority study
- No CNS metastases
- Over 18
- SWOG 0-2
- Karnofsky 60-100%
- More than 2 months
- WBC greater than 3,000/mm3
- Platelet count greater than 100,000/mm3
- Bilirubin less than 1.5 times normal
- Creatinine clearance at least 45 mL/min
- BUN less than 1.5 times normal
- No significant calcium abnormalities
- No symptomatic cardiovascular disease
- No New York Heart Association class II, III, or IV heart disease
- No congestive heart failure
- No angina pectoris
- No cardiac arrhythmia
- No uncontrolled hypertension
- No significant phosphate, electrolyte, or other metabolic abnormalities (e.g.,
- No uncontrolled psychiatric disorder or neurologic disease
- No seizure disorder
- No other malignancy within the past 5 years except curatively treated carcinoma in
situ of the cervix or skin cancer
- No other serious medical or psychiatric illness
- No uncontrolled serious infection
- No senility or emotional instability
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- Not specified
- No more than 2 prior chemotherapy regimens
- No more than 1 prior intraperitoneal chemotherapy regimen
- More than 6 weeks since prior chemotherapy
- No other concurrent chemotherapy
- No concurrent hormonal therapy except for nondisease-related conditions (e.g.,
insulin for diabetes)
- Concurrent steroids for antiemesis, premedication, adrenal failure, or septic shock
- No prior abdominal, pelvic, or lower chest radiotherapy
- Prior surgical resection preceding disease recurrence allowed
- More than 1 week since prior surgery