Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herbert Irving Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Gemcitabine; Interferon-gamma; Interferons; Liposomal doxorubicin; Mitomycin; Mitomycins

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