Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Over 18	NCI	CPMC-IRB-13799 NCI-G01-2015, NCT00024271

Objectives

1. 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.
2. Determine the toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed malignant mesothelioma
• Measurable or evaluable disease
• Ineligible for other high-priority study
• No CNS metastases

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

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

Expected Enrollment

A total of 15 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Robert Taub, MD, PhD, Protocol chair		Ph: 212-305-4076

Registry Information
Official Title		Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma
Trial Start Date		2001-05-23
Registered in ClinicalTrials.gov		NCT00024271
Date Submitted to PDQ		2001-07-26
Information Last Verified		2004-01-16
NCI Grant/Contract Number		P30-CA13696

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