University of Pittsburgh Cancer Institute (UPCI)

Clinical Studies

Clinical studiesLCP investigators are active in several clinical studies to test dose and efficacy of chemotherapy, including:

UPCI 11-104 (Socinski- PI)

Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (Nsc #736511, IND #74019) as Maintenance Therapy in Non-Progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB/IV Non-Small Cell Lung Cancer

Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether sunitinib is more effective than a placebo in treating non-small cell lung cancer. This multicenter randomized phase III trial, led by Dr. Mark Socinski at UPCI and sponsored by the Cancer and Leukemia Group B Foundation (CALGB) is studying sunitinib to see how well it works when given as maintenance therapy compared with a placebo in treating patients with stage III or stage IV non-small cell lung cancer previously treated with combination chemotherapy. Patients are stratified according to ECOG performance status (0 vs 1), disease stage (IIIB vs IV), prior treatment with bevacizumab (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral sunitinib malate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive oral placebo once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and periodically for 3 years.

UPCI 10-033 (Socinski- PI)

A Phase II Randomized Trial of Paclitaxel, Carboplatin, Bevacizumab with or without IMC-A12 in Patients with Advanced Non-Squamous, Non-Small Cell Lung Cancer

Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective when given with or without cixutumumab in treating patients with non-small cell lung cancer. This randomized phase II trial, led by Dr. Socinski at UPCI and sponsored by the Eastern Cooperative Oncology Group (ECOG) is studying giving paclitaxel and carboplatin together with bevacizumab to see how well it works when given with or without cixutumumab in treating patients with stage IV or recurrent non-small cell lung cancer.

Selected Publications

  • Combined inhibition of epidermal growth factor receptor (EGFR) and Src family kinases (SFK) may lead to improved therapeutic effects. In a phase I study, LCP investigators evaluated the combination of dasatinib, an inhibitor of SFK and other kinases, and cetuximab, an anti-EGFR monoclonal antibody in patients with solid tumors, including lung and esophageal cancers. Dasatinib 150 mg once daily plus weekly cetuximab is recommended for phase II studies (Argiris A, et. al., Invest New Drugs. 2011 Sep 1. [Epub ahead of print]).
  • Manganese superoxide dismutase (MnSOD) is a genetically engineered therapeutic DNA/liposome containing the human MnSOD transgene. Preclinical studies in mouse models have demonstrated that the expression of the human MnSOD transgene confers protection of normal tissues from ionizing irradiation damage. A phase I study evaluated MnSOD plasmid liposome (PL) in combination with standard chemoradiation in surgically unresectable stage III non-small-cell lung cancer. Oral administration of MnSOD PL is feasible and safe, and a phase II dose of 30mg is recommended (Tarhini AA, et. al., Hum Gene Ther. 22:336-42, 2011).

Members

Christie, Neil, MD
Surgery
Pennathur, Arjun, MD
Surgery
Dacic, Sanja, MD, PhD
Pathology
Sciurba, Frank, MD
Medicine
Fuhrman, Carl, MD
Radiology
Socinski, Mark, MD
Medicine
Gladwin, Mark, MD
Medicine
Weissfeld, Joel, MD, MPH
Epidemiology
Greenberger, Joel, MD
Radiation Oncology
Wilson, David, MD, MPH
Medicine
Heron, Dwight, MD, FACRO
Radiation Oncology
Yousem, Samuel, MD
Pathology
Luketich, James, MD
Surgery