Phase I
Study Title: A Pilot Study of SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine and Cyclophosphamide in Metastatic Colorectal Cancer as Maintenance Therapy
Study Type: Phase I/interventional/parallel assignment
Study Sponsor and Collaborators: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Purpose: To determine whether cyclophosphamide and a colon cancer cell vaccine in combination with SGI-110 is effective (recruits CD45RO-positive T cells to the tumor, which may be a marker of antitumor activity) and safe in patients with metastatic colon or rectal cancer
Primary Outcome Measures: Difference in CD45RO-positive tumor-infiltrating lymphocytes measured by immunohistochemistry in pre- and posttreatment tumor biopsies from patients with metastatic colorectal cancer; number of participants with adverse events as a measure of safety and tolerability [time frame: 4 years]
Principal Investigator: Nilofer Azad, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; nazad@jhmi@edu
ClinicalTrials.gov Identifier: NCT01966289
Study Title: Local Ablative Strategies After Endovascular Radioembolization (LASER)
Study Type: Phase I/interventional/parallel assignment
Study Sponsor and Collaborators: Washington University School of Medicine
Purpose: To study the initial utilization of a standard-of-care therapy for metastatic colorectal cancer (radioembolization) with a dose-calculation algorithm that has been verified as predictive for treatment response. Prediction of treatment failure will enable the proposed subsequent locoregional therapies, which were selected based on safety profiles and feasibility.
Primary Outcome Measures: Safety and tolerability of administering hepatic locoregional therapy following radioembolization as measured by occurrences of grade 3 or higher toxicities of interest [time frame: 30 days after completion of therapy (approximately 6 weeks)]
Principal Investigator: Parag Parikh, MD, Washington University School of Medicine; (314) 362-9703, pparikh@radonc.wustl.edu
ClinicalTrials.gov Identifier: NCT02611661
Phase I/II
Study Title: A Phase Ib/II Study of Cetuximab and Pembrolizumab in Metastatic Colorectal Cancer
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: Roswell Park Cancer Institute, National Cancer Institute
Purpose: To study the side effects and best dose of cetuximab when given together with pembrolizumab in treating patients with colorectal cancer that has metastasized from the primary site or that cannot be removed by surgery
Primary Outcome Measures: Incidence of adverse events, categorized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [time frame: up to 30 days after the last dose of study drug]; progression-free survival, evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [time frame: at 6 months]; tumor response rate, evaluated according to RECIST 1.1 [time frame: up to 2 years]
Principal Investigator: Patrick Boland, MD, Roswell Park Cancer Institute; (877) 275-7724,
askrpci@roswellpark.org
ClinicalTrials.gov Identifier: NCT02713373
Phase II
Study Title: An Open-Label, Multicenter, Phase II Study of Switch Maintenance With TAS-102 Plus Bevacizumab Following Oxaliplatin or Irinotecan-Based Fluoropyrimidine-Containing Induction Chemotherapy in Patients With Metastatic Colorectal Cancer
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: Georgetown University
Purpose: To study TAS-102, an oral agent that combines trifluridine and tipiracil hydrochloride, plus bevacizumab switch maintenance therapy in patients with metastatic colorectal cancer
Primary Outcome Measures: Progression-free survival [time frame: 5 years]
Principal Investigator: Mohamed Salem, MD, Georgetown University; contact Karen Vogel, RN; (202) 687-6974, kd252@georgetown.edu
ClinicalTrials.gov Identifier: NCT02654639
Study Title: Modulation of Autophagy: A Clinical Study of Vorinostat Plus Hydroxychloroquine vs Regorafenib in Refractory Metastatic Colorectal Cancer Patients
Study Type: Phase II/interventional/crossover assignment
Study Sponsor and Collaborators: The University of Texas Health Science Center at San Antonio
Purpose: To study patients with histologic documentation of metastatic colorectal cancer, who have received local and currently approved standard therapies, excluding regorafenib, and their response to vorinostat plus hydroxychloroquine vs regorafenib
Primary Outcome Measures: Efficacy based on progression-free survival of vorinostat and hydroxychloroquine compared with regorafenib [time frame: every 8 weeks]
Principal Investigator: Devalingam Mahalingam, MD, University of Texas Health Science Center at the Cancer Therapy and Research Center; contact Epp Goodwin, (210) 450-5798, ctrcreferral@uthscsa.edu
ClinicalTrials.gov Identifier: NCT02316340
Phase II/III
Study Title: A Phase II/III Trial of Neoadjuvant FOLFOX With Selective Use of Combined-Modality Chemoradiation vs Preoperative Combined-Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection With Total Mesorectal Excision (PROSPECT)
Study Type: Phase II/III/interventional/parallel assignment
Study Sponsor and Collaborators: Alliance for Clinical Trials in Oncology, National Cancer Institute
Purpose: To compare the effects of the standard treatment of chemotherapy and radiation to chemotherapy using the combination regimen FOLFOX (fluorouracil, oxaliplatin, and leucovorin) and selective use of the standard treatment, depending on response to FOLFOX
Primary Outcome Measures: Pelvic R0 resection rate (phase II); disease-free survival (phase III); time to local recurrence [time frame: 8 years]
Principal Investigator: Deborah Schrag, MD, Dana-Farber Cancer Institute; (617) 582-8301
ClinicalTrials.gov Identifier: NCT01515787
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov. ■
