A Phase II Feasibility Study of Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate
- Patients will undergo surgery called extrapleural pneumonectomy which involves removal
of the lung, the lining of the lung, the covering of the heart, and the muscle that
separates the chest and abdomen. At the conclusion of the resection, if the patient
has less then 1 cm3 of residual gross disease in one or more areas, then the heated
chemotherapy lavage will begin. If more than this volume of disease is present, then
the patient will receive additional treatment off-study.
- The chemotherapy treatment consists of a one-hour lavage of the chest and abdomen
cavity with heated cisplatin given in the operating room through the surgical incision.
At the completion of the hour, sodium thiosulfate is given intravenously to reduce the
potential side effects of cisplatin.
- During the surgery and for four hours following the completion of the cisplatin lavage,
blood samples, urine samples, chest wall muscle samples, and samples of the
chemotherapy solution will be done in order to measure the concentration of
chemotherapy and the impact of cisplatin on the various cell samples.
- Patients will remain in the hospital until they have recovered from surgery (7-14
days). Following discharge from the hospital, patients will be seen 1-2 weeks
post-operatively for blood tests. 6 weeks later additional blood tests and and
echocardiogram will be performed. This echocardiogram will be repeated 6 months
post-operatively to re-assess heart function.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To monitor tumor recurrence and patient survival, and compare those results to historic controls.
David J. Sugarbaker, MD
Brigham and Women's Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|