UF Health Cancer Center Supports Targeted Investigator-Initiated Trials to Address Areas of Need
In late 2023, the UF Health Cancer Center began issuing a series of competitive funding opportunities directly aimed at addressing strategic areas of need in the clinical trial portfolio. The first opportunity was a request for studies addresses women’s cancers. One of the awarded studies began enrollment on Aug. 20, 2024, examining manual versus image-guided lymphatic draining after axillary node dissection for breast cancer (PI: Lisa Spiguel, MD; NCT06327490). The other successful application is a novel trial examining smoking cessation techniques for women who wish to undergo reconstruction after mastectomy (PI: Jennifer Fieber, MD; NCT06461650), scheduled to begin enrollment in fall 2024.
The importance of these targeted funding opportunities is that they are based upon careful examination of the UF Health Cancer Center’s current trial portfolio in the context of our patient population and developed in an attempt to provide more inclusive and relevant trial opportunities for our patients.
Currently, there is a funding opportunity for interventional study proposals that have the potential to include a large number of UF Health patients.
Highlighted Clinical Trials Open for Enrollment
This study will test the hypothesis that a novel combination of three drugs (sorafenib, sonidegib, and irinotecan), in conjunction with individually optimized doses, can be safely administered and lead to improved clinical outcomes in patients with hepatocellular carcinoma compared to standard of care. The main objective of this study is to establish safe dose ranges for the coadministration of sorafenib, sonidegib, and irinotecan in patients with hepatocellular carcinoma. Furthermore, we will collect data to inform the application of an artificial intelligence/computational approach to individual dosing of combination chemotherapy.
Principal Investigator: Ali Zarrinpar, M.D., Ph.D.
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.
Principal Investigator: Paul Crispen, M.D. Contact: Phase1@cancer.ufl.edu
Palbociclib and Binimetinib in RAS-Mutant Cancers
This phase II ComboMATCH treatment trial evaluates the effectiveness of dual kinase inhibition with palbociclib and binimetinib in treating patients with RAS-mutated low-grade serous ovarian cancer (LGSOC). We are currently recruiting for MEK-inhibitor naïve LGSOC patients with RAS mutations including: RAS, KRAS, NRAS, HRAS, non-BRAF V600E, or rare RAF fusions, and LGSOC that is r/r to MEK-inhibitor therapy.
Principal Investigator: Thomas George, M.D. Contact: 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.
Principal Investigator: Kathryn Hitchcock, M.D.
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy for Limited mCRC (ERASur)
This phase III trial compares total ablative therapy (TAT) and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The ablative local therapy will consist of stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for Limited mCRC. This study is based on current common practice, and will pragmatically evaluate the safety, benefits versus risks, and survival impact of the integration of these treatments for Limited mCRC.
Principal Investigator: Kathryn Hitchcock, M.D.
Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer
A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer
This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, 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 and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).
Principal Investigator: Ibrahim Nassour, M.D., MSCS