A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
PI: Merry Markham, M.D. | merry.markham@medicine.ufl.edu
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer to determine need for adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) shed into the bloodstream represents a highly specific and sensitive approach (especially with serial monitoring) for identifying microscopic or residual tumor cells in colon cancer patients and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. Colon cancer patients who do not have detectable ctDNA (ctDNA-) are at a much lower risk of recurrence and may not need adjuvant chemotherapy. Furthermore, for colon cancer pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal adjuvant chemotherapy regimen has not been established. We hypothesize that for pts whose colon cancer has been resected, ctDNA status may be used to risk stratify for making decisions about adjuvant chemotherapy.
PI: Thomas George, M.D. | tgeorge@ufl.edu
This phase II/III trial compares the effect of adding chemotherapy before and after surgery versus after surgery alone (usual treatment) in treating patients with stage II-III gallbladder cancer. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before surgery may make the tumor smaller; therefore, may reduce the extent of surgery. Additionally, it may make it easier for the surgeon to distinguish between normal and cancerous tissue. Giving chemotherapy after surgery may kill any remaining tumor cells. This study will determine whether giving chemotherapy before surgery increases the length of time before the cancer may return and whether it will increase a patient’s life span compared to the usual approach.
PI: Ibrahim Nassour, M.D. | ibrahimnassour@ufl.edu
A phase II trial testing whether TRC102 (methoxyamine hydrochloride) in combination usual care treatment comprised of pemetrexed, cisplatin or carboplatin, and radiation therapy followed by durvalumab works better than the usual care treatment alone to shrink tumors in patients with stage III non-squamous non-small cell lung cancer (NSCLC). Giving TRC102 in combination with usual care treatment may be more effective than usual care treatment alone in stabilizing and lengthening survival time in patients with stage III non-squamous NSCLC.
PI: Tithi Biswas, M.D. | Phase1@cancer.ufl.edu
This is a phase II multicenter study of Lutetium Lu 177 Dotate (Lu-177 Dotate) in combination with Triapine vs. Lu-177 Dotate alone in metastatic well-differentiated somatostatin receptor-positive neuroendocrine tumors, after the failure of at least one prior line of systemic treatment. Subjects will be randomized 1:1 to either Lu-177 Dotate w/ oral triapine vs. Lutathera alone. Treatment is given in 8 week cycles, with IV Lu-177 Dotate on Day 1 of each cycle, with Triapine 150 mg QD Days 1-14. Participants can receive up to 4 Cycles of treatment.