An interventional, open-label, phase I study aimed at determining the maximum tolerated dose of pemetrexed combined with cisplatin when administered directly into the chest during surgery is currently underway in patients with malignant pleural mesothelioma at the Mesothelioma Treatment Center at the Baylor College of Medicine Lung Institute.
Shawn S. Groth, M.D., assistant professor of surgery at Baylor and the study’s principal investigator, is leading this study along with Dr. David Sugarbaker—one of the world’s leading experts in the treatment of malignant pleural mesothelioma.
Caused by inhalation of asbestos fibers, malignant pleural mesothelioma is a rare, yet aggressive, cancer that develops in the pleura—the thin layer of tissue that lines the lungs and the chest wall—and that does not present with symptoms until years after the initial exposure to asbestos occurred. The standard course of treatment for this disease is a combination of surgery and chemotherapy and/or radiation therapy. However, according to Dr. Groth in a press release from Baylor on December 20, 2016, this standard of treatment rarely prohibits a recurrence of mesothelioma: “Even after aggressive treatment with surgery, chemotherapy and/or radiation, recurrence is common. This study expands on what we already know about surgery and chemotherapy for mesothelioma and combines them in a new way – giving complete standard-of-care chemotherapy directly into the chest where we can potentially maximize its benefits while minimizing its side effects with the goal of reducing recurrence rates and improving survival and quality of life.”
Researchers at the Mesothelioma Treatment Center have already proven that cisplatin administered alone during surgery via heated chemotherapy does offer a survival benefit for some patients. Additionally, they have witnessed a more effective treatment outcome for some patients with a combination of cisplatin and pemetrexed administered via standard IV chemotherapy. The question that remains, and the one this clinical trial hopes to begin to answer, is whether the same combination of cisplatin and pemetrexed proves to be effective when administered directly into the chest during surgery.
This study, officially titled Phase I Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas, is currently enrolling and estimated enrollment is 36 patients. Complete details regarding this trial can be found at ClinicalTrials.gov. Patients and/or their caregivers who wish to obtain further information about this study, or who are interested in enrolling, may contact the Mesothelioma Treatment Center at Baylor College of Medicine at mesotreatmentcenter.org or call 713-798-6376. The anticipated study completion date is August 2018.Sources
Baylor College of Medicine