Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma

April 21, 2014

Primary Objective:

To establish the maximally tolerated dose (MTD) of intraoperative Intrathoracic/Intraperitoneal hyperthermic gemcitabine and cisplatin combination modulated by amifostine and sodium thiosulfate in patients with malignant pleural mesothelioma. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Objectivess:

To determine and quantitate the safety of this combination in these patients by defining the dose limiting toxicity. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To study the pharmacokinetics of gemcitabine and cisplatin combination administered in this way. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Eligibility Criteria

Inclusion Criteria:
Histologically-proven diagnosis of stages I to III malignant mesothelioma of the pleura and negative mediastinal N2 lymph nodes (Malignancy is confined to the affected hemithorax) Adequate organ function including the following: adequate cardiac function, pulmonary function, renal and hepatic function and bone marrow reserve Adequate overall physical activity Surgical candidate for cytoreductive surgery
Exclusion Criteria:
Extended disease outside the ipsilateral hemithorax as proven histologically, radiologically and/or intraoperatively Have received chemotherapy and or radiation therapy within the last 3 years at the time of study entry Serious concomitant systemic disorders Second active primary malignancy (to exclude non- melanoma skin cancer) Pregnancy at the time of the operation Psychiatric or addictive disorder which would preclude obtaining informed consent

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