This Clinical Trials Resource Guide lists actively recruiting trials on colorectal cancer, focusing on novel treatments, combinations of treatments, and testing options to determine which patients may be most likely to benefit from further treatment. More information on these trials is available on the National Institutes of Health’s website at ClinicalTrials.gov.
PHASE I
Study Title: A Phase I Study of Niclosamide in Patients With Resectable Colon Cancer
Study Type: Interventional/single-group assignment
Study Sponsor/Collaborators: Michael Morse, MD, Duke University
Purpose: To determine the maximum tolerated dose, safety data, and pharmacokinetic data on the changes in WNT pathway signaling following administration of niclosamide in patients with colon cancer undergoing primary resection
Primary Outcome Measures: Dose-limiting toxicity [time frame: 5 days]
Principal Investigator: Michael Morse, MD, Duke University; contact Dr. Morse at (919) 684-5705 or Michael.morse@dm.duke.edu or contact Wanda Honeycutt, RN, BSN, CCRP, at (919) 668-1861 or wanda.honeycutt@dm.duke.edu
ClinicalTrials.gov Identifier: NCT02687009
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Study Title: Pharmacodynamic Effects of Fatty Acid Synthase Inhibition With TVB-2640 in Resectable Colon Cancer and Other Resectable Cancers: A Window Trial
Study Type: Interventional/parallel assignment
Study Sponsor/Collaborators: Mark Evers, MD, Lucille P. Markey Cancer Center, University of Kentucky
Purpose: To evaluate the pharmacodynamic effects of short-term treatment with TVB-2640 on malonyl carnitine and tripalmitin levels in patients with resectable colon cancers
Primary Outcome Measures: Malonyl carnitine and tripalmitin levels in blood samples measured pre- and posttreatment using mass spectrometry
Principal Investigator: Mark Evers, MD, Lucille P. Markey Cancer Center, University of Kentucky, at mark.evers@uky.edu
ClinicalTrials.gov Identifier: NCT02980029
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PHASE I/II
Study Title: Phase I/II Study of CB-839 and Capecitabine in Patients With Advanced Solid Tumors and Fluoropyrimidine-
Resistant PIK3CA-Mutant Colorectal Cancer
Study Type: Interventional/single-group assignment
Study Sponsor/Collaborators: Case Comprehensive Cancer Center
Purpose: Phase I: To determine the safety, tolerability, and recommended phase II dose of combination CB-839 and capecitabine chemotherapy in patients with advanced solid tumors for whom there are no remaining treatment options or for whom single-agent capecitabine is an acceptable therapy. Phase II: To determine the disease control rate of the combination in patients with metastatic PIK3CA-mutant colorectal cancers who are refractory to fluoropyrimidine-based therapy
Primary Outcome Measures: Phase I: Recommended dose for the phase II study [time frame: after at least 21 days of treatment]. Phase II: Number of patients with response to treatment [time frame: up to 18 months after beginning treatment]
Principal Investigator: David Bajor, MD, University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center, at david.bajor@UHhospitals.org
ClinicalTrials.gov Identifier: NCT02861300
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PHASE II/III
Study Title: Phase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Patients With Stage IIA Colon Cancer (COBRA)
Study Type: Interventional/parallel assignment
Study Sponsor/Collaborators: NRG Oncology/NCI
Purpose: Phase II: To compare the rate of circulating tumor DNA (ctDNA) clearance in “ctDNA-detected” patients treated with or without adjuvant chemotherapy following stage IIA colon cancer. Phase III: To compare recurrence-free survival in “ctDNA-detected” patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer
Primary Outcome Measures: Phase II: Clearance of ctDNA to undetectable levels for the “baseline ctDNA–detected” patient subset [time frame: baseline up to 6 months]. Phase III: Recurrence-free survival of the “baseline ctDNA–detected” patient subset [time frame: time to recurrence or death, assessed up to 3 years]
Principal Investigator: Van K. Morris, MD, NRG Oncology; contact Judy Langer at (412) 339-5300 or langerj@nrgoncology.org
ClinicalTrials.gov Identifier: NCT04068103
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PHASE III
Study Title: Early Identification and Treatment of Occult Metastatic Disease in Stage III Colon Cancer
Study Type: Interventional/parallel assignment
Study Sponsor /Collaborators: Massachusetts General Hospital/Stand Up To Cancer
Purpose: To compare standard-of-care treatment options (active surveillance, FOLFIRI treatment [irinotecan, leucovorin, fluorouracil], nivolumab treatment, encorafenib/binimetinib/cetuximab treatment) based on blood test results
Primary Outcome Measures: Disease-free survival [time frame: 5 years] and clearance rate of ctDNA [time frame: 7 months]
Principal Investigator: Aparna Parikh, MD, Massachusetts General Hospital; contact Dr. Parikh at (617) 724-4000 or Aparna.Parikh@mgh.harvard.edu
ClinicalTrials.gov Identifier: NCT03803553
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Study Title: Randomized Trial of Standard Chemotherapy Alone or Combined With Atezolizumab as Adjuvant Therapy for Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Study Type: Interventional/parallel assignment
Study Sponsor/Collaborators: National Cancer Institute
Purpose: To determine whether atezolizumab plus oxaliplatin, leucovorin, and fluorouracil (FOLFOX) and its continuation as monotherapy can improve disease-free survival vs FOLFOX alone in patients with stage III colon cancers and deficient DNA mismatch repair
Primary Outcome Measures: Disease-free survival [time frame: from treatment randomization to first documentation of disease recurrence or death, assessed up to 5 years]
Principal Investigator: Frank A. Sinicrope, MD, Alliance for Clinical Trials in Oncology; for contact information, see the trial page on ClinicalTrials.gov.
ClinicalTrials.gov Identifier: NCT02912559
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.
