From the blog

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

Published: 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
Contact Us
Have you received a diagnosis? *