A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma

Inclusion Criteria:

• Patient age 18 years or older, both sexes.

• Clinical diagnosis of MPM at enrolling institution.

• Prior to randomization, intraoperative pathologic confirmation of epithelioid MPM atenrolling institution.

• Complete or near-complete CRS achieved.

• Patient must be planning to undergo complete cytoreduction of all peritonealdisease.

• ECOG performance status ≤ 1.

• Hematology: ANC ≥ 1,500/µl.

• Platelets > 75,000/µl.

• Adequate renal function: creatinine < 1.5× the upper limit of normal (ULN) orcalculated creatinine clearance of ≥50 ml/min.

• Adequate hepatic function: bilirubin < 1.5 mg/dl (except in patients with Gilbert'ssyndrome, who must have total bilirubin < 3.0 mg/dL).

• Women of childbearing potential with a negative pregnancy test result (urine orblood) who agree to use an effective contraceptive method. Reliable contraceptionshould be used from trial screening and must be continued throughout the study. Awoman of childbearing potential is defined as one who is biologically capable ofbecoming pregnant.

• A man participating in this study must agree to utilize a reliable barrier form ofcontraception for the duration of the study

• Signed and dated written informed consent to participate in this clinical trial mustbe obtained prior to any study procedure.

Exclusion Criteria:

• Subjects who have previously undergone intraperitoneal chemotherapy or systemicchemotherapy for peritoneal mesothelioma.

• Subjects who have previously received platinum-containing chemotherapy regimens.

• Subjects with preoperative or intraoperative biopsy consistent with sarcomatoidmesothelioma, well-differentiated papillary mesothelioma, or benign multicysticmesothelioma.

• Other prior malignancies, except for cured non-melanoma skin cancer, curativelytreated in situ carcinoma of the cervix, adequately treated malignancies for whichthere has been no evidence of activity for more than three years, or indolent tumorsfor which observation over two years is a reasonable option.

• High suspicion for extra-abdominal metastases.

• Women who are pregnant or lactating.

• Active coronary artery disease (defined as unstable angina or a positive cardiacstress test). Subjects with a history of coronary artery disease may be included ifthey have had a normal stress test within 60 days of enrollment or are determined bya cardiologist to be of acceptable perioperative risk.

• Uncontrolled hypertension defined as >140/90 and not cleared for surgery at the timeof consent.

• New York Heart Association (NYHA) Class II or higher congestive heart failure;restrictive or obstructive pulmonary disease that would limit study compliance orplace the patient at unacceptable risk for participation in the study.

• History of cerebrovascular disease that would limit study compliance or place thepatient at unacceptable risk for participation in the study.

• Subjects with other concurrent severe medical problems unrelated to the malignancythat would significantly limit full compliance with the study or place them at anunacceptable risk for participation in the study.

• Patients with known cisplatin, carboplatin, pemetrexed or mitomycin allergy.

• Evidence of extensive intraperitoneal adhesions at the time of surgery whichprohibits intraperitoneal therapy, as determined by the operating surgeon.

• Any condition that would preclude the ability to deliver appropriate IP therapy.

• Use of an oral medication, lacking a suitable non-oral substitute, that if held forup to ten days, would be felt an unacceptable risk by the investigator.

• Life expectancy < 12 weeks.