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Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Mesothelioma

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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 UniversityNew York, New York  10032