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

Exclusion Criteria16

• Subjects who have previously undergone intraperitoneal chemotherapy or systemic chemotherapy for peritoneal mesothelioma.
• Subjects who have previously received platinum-containing chemotherapy regimens.
• Subjects with preoperative or intraoperative biopsy consistent with sarcomatoid mesothelioma, well-differentiated papillary mesothelioma, or benign multicystic mesothelioma.
• Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than three years, or indolent tumors for 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 cardiac stress test). Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 60 days of enrollment or are determined by a cardiologist to be of acceptable perioperative risk.
• Uncontrolled hypertension defined as \>140/90 and not cleared for surgery at the time of consent.
• New York Heart Association (NYHA) Class II or higher congestive heart failure; restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.
• History of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.
• Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or place them at an unacceptable 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 which prohibits 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 for up to ten days, would be felt an unacceptable risk by the investigator.
• Life expectancy \< 12 weeks.