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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Malignant Mesothelioma	Biological: recombinant interferon gamma; Drug: cisplatin; Drug: doxorubicin hydrochloride; Drug: gemcitabine hydrochloride; Drug: mitomycin C; Procedure: conventional surgery; Procedure: hyperthermia treatment; Radiation: radiation therapy	Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Primary Purpose:	Treatment
Official Title:	Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma
Study Start Date :	May 2001

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032

Sponsors and Collaborators

Herbert Irving Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Robert N. Taub, MD, PhD	Herbert Irving Comprehensive Cancer Center

More Information

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ClinicalTrials.gov Identifier:	NCT00024271 History of Changes
Other Study ID Numbers:	CDR0000068907; CPMC-IRB-13799; NCI-G01-2015
First Posted:	January 27, 2003
Last Update Posted:	January 6, 2014
Last Verified:	January 2004

Keywords provided by National Cancer Institute (NCI):

localized malignant mesothelioma; advanced malignant mesothelioma; recurrent malignant mesothelioma

Additional relevant MeSH terms:

Mesothelioma; Lung Neoplasms; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Gemcitabine; Interferons; Interferon-gamma	Doxorubicin; Mitomycin; Liposomal doxorubicin; Mitomycins; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antibiotics, Antineoplastic