Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma
18 Years
N/A
Both
Malignant Mesothelioma
Trial Information
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant mesothelioma
- Measurable or evaluable disease
- Ineligible for other high-priority study
- No CNS metastases
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- SWOG 0-2
- Karnofsky 60-100%
Life expectancy:
- More than 2 months
Hematopoietic:
- WBC greater than 3,000/mm3
- Platelet count greater than 100,000/mm3
Hepatic:
- Bilirubin less than 1.5 times normal
Renal:
- Creatinine clearance at least 45 mL/min
- BUN less than 1.5 times normal
- No significant calcium abnormalities
Cardiovascular:
- 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
Other:
- No significant phosphate, electrolyte, or other metabolic abnormalities (e.g.,
metabolic acidosis)
- 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:
Biologic therapy:
- Not specified
Chemotherapy:
- 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
Endocrine therapy:
- No concurrent hormonal therapy except for nondisease-related conditions (e.g.,
insulin for diabetes)
- Concurrent steroids for antiemesis, premedication, adrenal failure, or septic shock
allowed
Radiotherapy:
- No prior abdominal, pelvic, or lower chest radiotherapy
Surgery:
- Prior surgical resection preceding disease recurrence allowed
- More than 1 week since prior surgery
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Robert N. Taub, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Herbert Irving Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068907
NCT ID:
NCT00024271
Start Date:
May 2001
Completion Date:
Related Keywords:
- Malignant Mesothelioma
- localized malignant mesothelioma
- advanced malignant mesothelioma
- recurrent malignant mesothelioma
- Mesothelioma
Name | Location |
|---|---|
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
