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:
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- 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:
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- 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
