Moffitt Cancer Center in Tampa, Florida, is currently seeking participants for a Phase 2 Study of Transarterial Chemoperfusion Treatment with Cisplatin (TCTC), Methotrexate and Gemcitabine in Patients with Unresectable Pleural Mesothelioma. “The purpose of the study,” explains Moffitt “is to determine whether the transarterial chemoperfusion treatment with cisplatin, methotrexate and gemcitabine is safe and effective in adults with malignant pleural mesothelioma.” The study will also assess overall survival (OS), progression free survival (PFS), and quality of life in patients, as well as the frequency and severity of adverse events related to the treatment during the chemoperfusion phase and follow-up phase of the study.
Drugs used in chemotherapy, such as cisplatin, methotrexate and gemcitabine, work in different ways to stop the growth of tumor cells by killing the cells, stopping them from spreading or stopping them from dividing. Transarterial Chemoperfusion is a procedure that allows chemotherapy agents, such as cisplatin, methotrexate and gemcitabine, to be directly injected into the arteries that supply blood to the area where the tumor is located.
Led by Bela Kis, MD, PhD, the Phase 2 study shows great promise, so researchers are hopeful that it will move to Phase 3. Per the American Society of Clinical Oncology (ASCO), during this phase, researchers compare the treatment of care for that disease with two or more other treatment options. Phase 3 studies often take years to complete, but once the treatment has proven to be effective against a specific cancer, doctors can apply for FDA approval. If FDA standards are met, the FDA will approve the treatment for specific use.
Sources
"Bela Kis, MD, PhD." Moffitt Cancer Center. H. Lee Moffitt Cancer Center & Research Institute, 2017. Web. 03 May 2017.
Cancer.Net, Editorial Board. "Phases of Clinical Trials." Cancer.Net. American Society of Clinical Oncology (ASCO), 10 Dec. 2015. Web. 03 May 2017.
"Clinical Trial 18094 - A Phase 2 Study of Transarterial Chemoperfusion Treatment with Cisplatin, Methotrexate and Gemcitabine in Patients with Unresectable Pleural Mesothelioma." Moffitt Cancer Center. H. Lee Moffitt Cancer Center & Research Institute, 2017. Web. 03 May 2017.
Phases of Clinical Trials - An Introduction, with Neal Meropol, MD. Perf. Neal J. Meropol, MD, FASCO. Cancer.Net. American Society of Clinical Oncology (ASCO), Dec. 2015. Web. 03 May 2017.
"Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma." National Cancer Institute (NCI). National Institutes of Health (NIH), U.S. Department of Health and Human Services (HHS), 2017. Web. 03 May 2017.
