Phase I of the of Extrapleural
Pneumonectomy/Pleurectomy Decortication, Intrathoracic/Intraperitoneal
Hyperthermic (IOHC) Cisplatin and Gemcitabine With Intravenous Amifostine and
Sodium Thiosulfate Cytoprotection for Patients With Resectable Malignant
Pleural Mesothelioma study, is currently recruiting patients
to study the efficacy of Gemcitabine and Cisplatin administered in the
operating room directly into the chest and abdomen for one hour. In addition,
researchers are also gauging the effects of heating this chemotherapy treatment
to a temperature of 42 degrees Celsius, as well as the effects of the
Cytoprotection agents Amifostine and Sodium Thiosulfate to counteract the chemotherapy’s
side effects.
This trial, which was last updated on
ClinicalTrials.gov on October 30, 2009 and that has an estimated enrollment of
36, is a dose escalation study of Gemcitabine with a fixed dose of
Cisplatin. Recruits will undergo
cytoreductive surgery, which entails the removal of the inner and outer lining
of the lung (pleurectomy/decortication) with or without the lung itself (extrapleural
pneumonectomy), and the lining overlying the pericardium and diaphragm. After surgery, a one hour lavage with heated Cisplatin
and/or Gemcitabine is administered to the hemithorax. Recruits will remain hospitalized between 7-14 days to recover from
surgery and must return to the hospital during the first month after surgery
for evaluation by the medical staff.
Mesothelioma
is a rare type of cancer that occurs in the lining of the chest or abdomen. It
is more likely to develop in individuals who have been exposed to airborne
asbestos particles, and treatment can include mesothelioma surgery,
chemotherapy, radiation or a combination of the three. However, the surgery mentioned as part of
this study is not standard care for malignant pleural mesothelioma.
Thoracic
oncologists, such as the trial’s principal investigator, the internationally
recognized Dr.
Sugarbaker, stand to benefit greatly from the information produced by the
aforementioned study. Trial results
should establish the maximally tolerated dose of intraoperative
Intrathoracic/Intraperitoneal hyperthermic Gemcitabine and Cisplatin when
modulated by Amifostine and Sodium Thiosulfate in patients with malignant pleural mesothelioma. They should also determine
the safety of this combination and define the dose limiting toxicity, while
observing the pharmacokinetics of Gemcitabine and Cisplatin administered in
this way.
Both men
and women, 18 years or older, are eligible to participate in the study. Recruits must have a histologically-proven
diagnosis of stages I to III malignant mesothelioma of the pleura and negative
mediastinal N2 lymph nodes. The patients
must have adequate overall physical activity, cardiac function, pulmonary
function, renal and hepatic function and bone marrow reserve. They must also be
appropriate candidates for cytoreductive surgery.
Patients
with disease outside of the ipsilateral hemithorax, serious concomitant
systemic disorders, a second active primary malignancy or a psychiatric or
addictive disorder are not eligible for participation in this study. Nor are pregnant patients or those who have
received chemotherapy and or radiation therapy within the 3 years prior to
study entry.
For more
information on this trial visit: http://clinicaltrials.gov/ct2/show/NCT00571298?term=mesothelioma&rank=11.
Refer to the study by its ClinicalTrials.gov identifier: NCT00571298
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