The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies of people with colon or rectal cancer in the newly diagnosed and metastatic settings. The studies include phase I, Ib, II, observational, and interventional trials investigating new drug combinations, drug and radiation combinations, stereotactic radiosurgery, chemoradiation, chemotherapy toxicities among elderly patients, palliative care intervention for caregivers, mindfulness-based intervention program, physician-adherence to NCCN Survivorship Care Guidelines, and PET-CT and PET-MRI imaging. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
PHASE I/Ib/II
Study Type: Phase I/interventional/single-group assignment
Study Title: A Phase IB Study of the Combination of AZD6244 Hydrogen Sulfate (Selumetinib) and Cyclosporin A (CsA) in Patients With Advanced Solid Tumors With an Expansion Cohort in Metastatic Colorectal Cancer
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To investigate the side effects and best dose of selumetinib when given with cyclosporine in treating patients with solid tumors or colorectal cancer that has spread to other places in the body and cannot be cured or controlled with treatment
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Incidence of dose-limiting toxicity, defined as any grade 3 nonhematologic toxicity or grade 4 hematologic toxicity attributed to selumetinib or cyclosporine graded per NCI CTCAE version 4.0 (time frame: 28 days).
Principal Investigator: Christopher H. Lieu, MD, MD Anderson Cancer Center; 303-724-6390, Christopher.lieu@ucdenver.edu.
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02188264
Study Type: Phase I/interventional/nonrandomized
Study Title: A Dose-Finding, Safety and Preliminary Efficacy Study of Stereotactic Radiosurgery for Hepatocellular Carcinoma and Metastatic Disease to the Liver
Study Sponsor and Collaborators: UNC Lineberger Comprehensive Cancer Center
Purpose: To determine a tolerable dose of radiation delivered by the CyberKnife system in two groups of patients with hepatocellular carcinoma
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Tolerable doses of radiation in patients with liver cancer or metastases to the liver in patients with good vs compromised liver function (time frame: 6 years)
Principal Investigator: Joel Tepper, MD, University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center. Contact: Donna Rowe, RN, 919-966-4432, donna_rowe@med.unc.edu.
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01528878
Study Type: Phase I/II/interventional
Study Title: A Phase I/II Pharmacodynamic Study of Hydroxychloroquine in Combination With FOLFOX Plus Bevacizumab to Inhibit Autophagy in Colorectal Cancer
Study Sponsor and Collaborators: Abramson Cancer Center of the University of Pennsylvania
Purpose: To investigate the addition of hydroxychloroquine to the standard front-line therapy of colorectal cancer, FOLFOX/bevacizumab.
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: The investigators will use response as the primary efficacy marker to investigate the relationship between changes in autophagy markers and standardized uptake values and the efficacy of treatment.
Principal Investigator: Peter J. O’Dwyer, MD, Abramson Cancer Center of the University of Pennsylvania; 855-216-0098, penncancertrials@emergingmed.com.
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01206530
Study Type: Interventional/randomized/parallel assignment
Study Title: The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections
Study Sponsor and Collaborators: Comprehensive Cancer Center of Wake Forest University; National Cancer Institute
Purpose: To evaluate if a negative-pressure dressing placed over a surgical incision can reduce the risk of developing a surgical site infection compared to a commonly used sterile gauze incision dressing. In the study, patients will receive either a negative-pressure dressing or a standard sterile gauze dressing.
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Rate of incisional surgical site infection (SSI), which includes incisional SSIs and deep incisional SSIs as defined by the Centers for Disease Control and Prevention (time frame: 30 days).
Principal Investigator: Perry Shen, MD, 336-713-6913, pshen@wfubmc.edu.
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01656044
Study Type: Phase Ib/II/interventional/single-group assignment
Study Title: An Open Label, Two-Part, Phase Ib/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor Trametinib and the BCL2-Family Inhibitor Navitoclax (ABT-263) in Combination in Subjects With KRAS Mutation-Positive Advanced Solid Tumors
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To study the side effects and best dose of trametinib and navitoclax in treating patients with solid tumors that have spread to other places in the body or cannot be cured or controlled with treatment. Trametinib and navitoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Incidence of adverse events graded according to National Cancer Institute CTCAE v4.0 phase Ib and II (time frame: up to 30 days)
Principal Investigator: Ryan Corcoran, MD, PhD, Dana-Farber Cancer Institute; 617-726-8599, rbcorcoran@partners.org.
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02079740
Study Type: Phase II/interventional/randomized
Study Title: A Phase II Multicenter Randomized Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Nonoperative Management
Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center, Colon and Rectal Surgery Inc, The Cleveland Clinic, John Muir Health, Oregon Health and Science University, St. Joseph Hospital Health Center, University of Calgary, University of California, Irvine, University of California, San Francisco, University of Chicago, University of South Florida, University of Vermont, University of Washington, Washington Hospital Center, Washington University Early Recognition Center, Bergan Mercy Medical Center, The Methodist Hospital System, University of Rochester, University of Virginia, St. Paul’s Hospital
Purpose: To test the hypothesis that patients with distal locally advanced rectal cancer treated with total neoadjuvant therapy and total mesorectal excision or nonoperative management will have an improved 3-year disease-free survival compared to patients with similar tumors treated with chemoradiation therapy, total mesorectal excision, and adjuvant chemotherapy.
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Disease-free survival (time frame: 3 years)
Principal Investigator: Julio Garcia Aguilar, MD, PhD, Memorial Sloan Kettering Cancer Center; 212-639-5117
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02008656
Study Type: Phase II/interventional/single-group assignment
Study Title: A Phase II Trial of Maintenance ADAPT Therapy With Capecitabine and Celecoxib in Patients With Metastatic Colorectal Cancer
Study Sponsor and Collaborators: University of Washington; National Cancer Institute
Purpose: To study how well capecitabine and celecoxib with or without radiation therapy works in treating patients with colorectal cancer that is newly diagnosed or has been previously treated with fluorouracil, and has spread to other parts of the body
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Rate of complete response, assessed according to CEA and CA 19-9 measurements and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (time frame: 3 years).
Principal Investigator: Edward Lin, MD, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 206-288-6678.
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01729923
Study Type: Phase II/interventional/single-group assignment
Study Title: A Phase 2 Study of MK-2206 in Previously Treated Metastatic Colorectal Cancer Patients Enriched for PTEN Loss and PIK3CA Mutation
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To investigate how well Akt inhibitor MK2206 works in treating patients with previously treated colon or rectal cancer that has spread from the primary site to other places in the body and cannot be removed by surgery.
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Overall response rate evaluated using RECIST version 1.1 (time frame: up to 18 months)
Principal Investigator: Edmund S. Kopetz, MD, MD Anderson Cancer Center; 713-792-2828, skopetz@mdanderson.org.
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01802320
OBSERVATIONAL
Study Type: Observational
Study Title: Pilot Study Assessing the Correlation Between Telomere Length and Chemotherapy-Related Toxicity Among Early Stage and Metastatic Colorectal Patients Over the Age of 70
Study Sponsor and Collaborators: Fox Chase Cancer Center; National Cancer Institute
Purpose: To study telomere length in predicting toxicity in older patients with stage III/IV colorectal cancer undergoing chemotherapy.
Ages Eligible for Study: 70 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Telomere length (time frame: up to 6 months). Telomere length will be compared between participants experiencing at least one adverse event and those who experience none using the Mann-Whitney test.
Principal Investigator: Efrat Dotan, MD, Fox Chase Cancer Center; 215-728-2500, efrat.dotan@fccc.edu.
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01934179
INTERVENTIONAL
Study Type: Interventional/randomized
Study Title: A Randomized Trial of a Family Caregiver Palliative Care Intervention
Study Sponsor and Collaborators: City of Hope Medical Center; National Cancer Institute, American Cancer Society
Purpose: To study the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, and urologic cancers. Education and telephone counseling may reduce stress and improve well-being and quality of life of caregivers of cancer patients.
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: Yes
Primary Outcome Measures: Effects of Family Caregiver Palliative Care Intervention on caregiver burden (time frame: up to 6 months)
Principal Investigator: Betty Ferrell, PhD, RN; 800-826-4673, bferrell@coh.org.
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01846520
Study Type: Interventional/randomized
Study Title: A Mindfulness-Based Educational Intervention for Colorectal Cancer Patients and Caregivers
Study Sponsor and Collaborators: University of Southern California; National Cancer Institute
Purpose: To determine the effectiveness of a mindfulness-based program in educating patients with colorectal cancer and their caregivers. A mindfulness-based exercise video may help reduce stress and fatigue in patients with the disease.
Ages Eligible for Study: 18 to 65 years
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Change in self-reported levels assessed using pre- and post-test assessments (time frame: baseline to up to 60 minutes). The intervention effects will be examined using multilevel modeling, including chi-square, t-tests, and one-way analyses of variance.
Principal Investigator: Jane Figueiredo, PhD, University of Southern California; 323-442-7752, janefigu@usc.org.
For More Information: ClinicalTrials.gov and refer to this study by its identifier: NCT02057991
Study Type: Interventional/nonrandomized/single-group assignment
Study Title: Adherence to NCCN Survivorship Care Guidelines in Non-Small Lung Cancer and Colorectal Cancer Survivor Care
Study Sponsor and Collaborators: Fox Chase Cancer Center
Purpose: To study adherence to survivorship care guidelines in health-care providers for non–small cell lung cancer or colorectal cancer survivor care. The completion of an educational intervention by health-care providers may increase compliance and adherence to National Comprehensive Cancer Network guidelines for survivorship care.
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Percentage of eligible colorectal cancer and non–small cell lung cancer survivors with medical record documentation of compliance with NCCN guidelines (time frame: up to 6 months)
Principal Investigator: Crystal Denlinger, MD, Fox Chase Cancer Center; 215-214-1676, crystal.denlinger@fccc.edu.
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT0172696
Study Type: Interventional/single-group assignment
Study Title: The Use of Fluorescent Imaging to Evaluate Bowel Anastomotic Perfusion
Study Sponsor and Collaborators: Maimonides Medical Center
Purpose: To utilize a special camera to evaluate the blood supply of the bowel. The new system called Spy-scope may assist surgeons in reducing the occurrence of leaks.
Ages Eligible for Study: 18 to 65 years
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Evaluate the vascular supply to bowel anastomoses (time frame: participants will be followed for the duration of the hospital stay, an expected average of 5 days, and then in the clinic at 1 week and 1 month postoperatively.
Principal Investigator: Danny A. Sherwinter, MD, Maimonides Medical Center; 718-283-7952, dsherwinter@maimonidesmed.org.
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01424293 ■
