• 1- and 2- year disease free survival [ Time Frame: baseline to post surgery ] [ Designated as safety issue: No ]
• To determine complete pathological response rate [ Time Frame: surgical complete response post chemotherapy, surgery and radiation ] [ Designated as safety issue: No ]
• Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
• Time to objective tumor response [ Time Frame: baseline to response of tumor ] [ Designated as safety issue: No ]
• Time to progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
• Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]

• -To determine the 1- and 2- year disease free survival, and median survival.
• -To determine complete pathological response rate
• -To determine clinical response rate measured by radiological assessment.
• -To characterize the quantitative and qualitative toxicities of chemotherapy, surgery and radiation in this patient population.
• -To determine the pattern of relapse (local versus metastatic).
• -To measure time-to-event efficacy variables including: time to objective tumor response for responding patients-time to progressive disease-overall survival

Phase II trial of Neoadjuvant Chemotherapy with Pemetrexed plus Cisplatin followed by Surgery and Radiotherapy in patients with Malignant Pleural Mesothelioma stage I-III.

The event-free survival is the primary endpoint for this study. This is a multicenter study and 53 Patients will be enrolled by June 2008.

• Drug: pemetrexed
• Drug: cisplatin

Inclusion Criteria

• Histological proven diagnosis of stages I to III mesothelioma of the pleura.
• Adequate organ function including the following: adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.
• No prior systemic chemotherapy
• No previous surgical resection of mesothelioma, with the exception of previous chemical pleurodesis.
• No previous radiation therapy.

Exclusion Criteria

• Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
• Serious concomitant systemic disorders
• Second active primary malignancy
• Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period
• Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone