Surgery Clinical Trials

Dr. David J. Sugarbaker has conducted multimodality clinical treatment trials, involving surgical resection by extrapleural pneumonectomy (EPP) or pleurectomy combined with intrathoracic/intraperitoneal heated chemotherapy. Three surgical clinical trials are currently opened and accruing patients: a Phase II (EPP) clinical trial, involving extrapleural pneumonectomy (removal of the lung and lining of the chest cavity) and heated chemotherapy applied to the chest and abdominal cavities during the operation, followed by chemotherapy and radiation; a Phase II (randomized Pleurectomy) clinical trial, involving pleurectomy (removal of the lining of the lung and chest cavity while preserving the lung) and heated chemotherapy during the operation followed by chemotherapy; and a Phase II ‘neoadjuvant’ trial involving treatment with the chemotherapy drugs ALIMTA and cisplatin, followed by an EPP, followed by radiation.

Because recurrence of the disease generally occurs on the same side where the tumor was removed, it was logical to pursue therapy to control this recurrence. Our approach was to pursue intraoperative, intracavitary, heated chemotherapy as a way to optimize control of local disease spread. We are conducting two trials utilizing intraoperative, intracavitary, heated chemotherapy but differing according the extent of surgical resection that the patient can tolerate. Extrapleural pneumonectomy represents the optimal procedure to reduce tumor burden to the microscopic level. A second trial, utilizing pleurectomy, is offered to patients who lack the cardiopulmonary reserve to undergo a pneumonectomy.

Phase II Feasibility study of Extrapleural Pneumonectomy (EPP) with Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin with Sodium Thiosulfate (Protocol 03-302) is active, not recruting patients. This study involves a treatment consisting of EPP (removal of both the lung and its lining) followed by heated chemotherapy (cisplatin) administered in the operating room and put into the chest and abdomen for one hour after the surgical removal of the cancer. The goal in this study is to use EPP to surgically remove the mesothelioma and to use the chemotherapy to contain the local spread of the disease. Extrapleural pneumonectomy represents the optimal procedure to reduce tumor burden to the microscopic level. Contact Stella at 617-732-5922.

Phase II Feasibility Study of Pleurectomy/Decortication with Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin with Sodium Thiosulfate Followed by Adjuvant ALIMTA®/Cisplatin (Protocol 04-063) is active, not recruting patients. This study is for patients who are surgical candidates for a pleurectomy/decortication (removal of the lining of the lung and visible disease) but lack the cardiopulmonary reserve to undergo a pneumonectomy. Patients will undergo pleurectomy/decortication followed by chemotherapy (cisplatin) administered in the operating room (cisplatin will be put into the chest and abdomen for one hour after the surgical removal of the cancer). Six to ten weeks following surgery, chemotherapy (ALIMTA® plus cisplatin) will be given.  Contact Stella at 617-732-5922.

A Multicenter Phase II Trial of Neo-Adjuvant ALIMTA® (Pemetrexed) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma(Protocol 03-132) is active, not recruting patients. This study involves up-front chemotherapy followed by extrapleural pneumonectomy (removal of both the lung and its lining) followed by radiation. ALIMTA® is an antifolate that works by interfering with a crucial process that allows mesothelioma cells to reproduce and spread. ALIMTA® has recently been approved by the FDA. ALIMTA® is being given along with a standard chemotherapy agent, cisplatin, which is often used in the treatment of cancers, including malignant pleural mesothelioma. The purpose of this study is to determine if giving chemotherapy before surgery will delay tumor growth and/or shrink the tumor, improving the chance of surgically removing the tumor. Contact Stella at 617-732-5922.