Palliative Care Clinical Trials

Our team is dedicated to clinical research in the field of palliative care. For more information on any of these trials, or to find out if you're eligible to participate, contact Carolyn Revta, Palliative Care Clinical Research Operations Director, or 858-822-3614.

Ongoing Studies

PledPharma PP095–PLIANT

Status: Currently recruiting identifier: NCT01619423
Eligible: Patients with metastatic colorectal cancer
The first line of treatment for patients with metastatic colorectal cancer is the combination chemotherapy FOLFOX (5–Fluorouracil, Leucovorin and Oxaliplatin), which is given as an intravenous (IV) infusion every two weeks. Although very effective in treating colorectal cancer, there are a number of side effects associated with this treatment regimen, including decreased white blood cell counts, sensory neuropathy of the hands and feet, and diarrhea. These side effects significantly impact a patient’s ability to tolerate treatment with FOLFOX and often result in dose reduction, dose delays, or early progression to a second line of chemotherapy. PledOx is an experimental drug designed to reduce the incidence and severity of these treatment related side effects. PledOx is a manganese-based treatment designed to reduce the toxic effects of chemotherapy in healthy cells. The goal of this open label phase II study is to assess the efficacy of two different doses of PledOx vs. placebo in protecting against side effects associated with the administration of FOLFOX in patients with metastatic colorectal cancer.

Eli Lilly I3S-MC-JABA

Status: Currently recruiting identifier: NCT01340976
Eligible: Patients on chemotherapy with anemia
Anemia is a condition characterized by weakness and/or fatigue and is caused by a low number of circulating red blood cells. The presence of anemia in cancer patients is reported to be between 30% and 90%. Many cancers are associated with inflammation that causes anemia by interfering with the release of iron into the plasma. Hepcidin is a small protein that plays a key role in regulating iron storage by binding to and blocking ferroportin, the protein channel through which iron is released into the blood. LY2787106 is an experimental drug developed by Eli Lilly that is designed to bind to and “capture” hepcidin, preventing it from blocking the flow of iron from cells into the plasma. The goal of this phase I study is to assess safety and effectiveness of LY2787106 in treating hepcidin-related anemia in patients with cancer. 

XBiotech 2012-PT023

Status: Currently recruiting identifier: NCT01767857
Eligible: Colorectal cancer patients
Cachexia is a metabolic weight loss syndrome characterized by an increase in metabolism and a decrease in hunger that leads to rapid and uncontrolled loss of lean body mass in cancer patients. Cachexia has significant impacts on quality of life, prognosis, and a patient’s ability to receive or tolerate chemotherapy. Xilonix is an experimental drug designed to reverse or stabilize weight loss in patients with advanced colorectal cancer. The active agent is an antibody that binds to and diminishes the effect of Interleukin 1-alpha (IL1-alpha), a protein that plays a key role in inflammation. In previous studies, Xilonix has reversed the process of cachexia in patients with progressive, metastatic disease. The primary goal of this study is to evaluate overall survival of colorectal cancer patients receiving Xilonix versus patients receiving standard treatment. This study will also evaluate changes in quality of life and lean body mass between the two groups.

RTOG-0631 – Phase II/III Study of Image-Guided Radiosurgery/ SBRT for Localized Spine Metastasis

Status: Currently recruiting identifier: NCT01461252
Eligible: Patients with spine metastases
Spine metastases are a common complication of many primary cancer types. Patients with spine metastases often experience severe back pain and other neurological complications that significantly impact quality of life and function. Traditional treatment for painful spine metastases has been fractionated external beam radiotherapy, but the efficacy of these treatments has varied from patient to patient. It has previously been shown that radiosurgery in which one higher radiation dose is administered in the localized region of the spinal tumor have been effective in rapid pain relief. This trial seeks to evaluate the efficacy of radiosurgery with a single fraction versus conventional external beam radiotherapy in managing pain caused by spinal metastases.



Carolyn Revta
Palliative Care Clinical Research Operations Director
Moores Cancer Center
Phone: 858-822-3614